Embed Size (px)
DESCRIPTION
International conference «Actual approaches to the extremely preterm babies: International experience and Ukrainian realities» (Kyiv, Ukraine, March 5-6, 2013)
Citation preview
Ethical issues of extremely
preterm babiesrsquo care
the ldquogrey zonerdquo experiences
Kyiv March 6th 2013
Dr Lucas Opitz
Anaesthesia and Intensive Care NICU - PICU
Centre Hospitalier Universitaire - GCS
Nice France
What are ethics
bull ldquoNothing is either good or bad but thinking makes
it sordquo (W Shakespearersquos Hamlet)
bull Branch of philosophy addresses questions about
morality = concepts such as good and bad right
and wrong justice and virtue
bull The study of the general nature of morals and of
the specific moral choices to be made by a person
or a profession
Are ethical choices in medicine easy to
define
bull Classical medical ethical convictions
Preserve life - at any cost
bull Life or death = all or nothing = 100 or 0
bull At the threshold of viability in preterm
babies ldquoin-between statusrdquo prognosis quod
valitudinem difficult to predict
Definition of ethical choices in medicine
bull Beneficence best interest of the patient (Salus aegroti suprema lex)
bull Non-maleficence first do no harm (primum non nocere)
bull Autonomy the patient has the right to refuse or choose his treatment
(Voluntas aegroti suprema lex)
bull Justice distribution of scarce health resources decision of who gets
what treatment
bull Dignity the patient (and the person treating the patient) have the right
to dignity
bull Truthfulness
bull Honesty
Ethics in neonatology influenced byhellip
bull Culture - religion - philosophy
bull Sociology - society
bull Individual convictions
bull Cost
bull Fears dilemmas taboos
bull Juridical backgrounds
Singh M Ethical and social issues in the care of the newborn Indian J Pediatr May 200370(5)417-20
Ethics in neonatology
- We touch the most profound interface between
materialistic objective medicine and emotional
empathy personal conviction
- Tragic situations leave only tragic options
bull Skin immaturity
bull Fluid balance instability
bull Lung immaturity and breathing problems
bull Malnutrition and gut damage
bull Retinopathy of prematurity
bull Early and late onset infections
bull Brain damage which can lead to a spectrum of long-term
neurological sequelae = THE MAIN ETHICAL ISSUE
ldquoIn Preemies Better Care Also Means Hard Choicerdquo (New York Times August 13 2012)
Where do we touch the limits
Brain development
bull 12-16 weeks neuronal proliferation
bull 12 - 20 weeks neuronal migration
bull 20 weeks neuronal organisation inside-out layering
of the cortical neurones synaptogenesis
bull 26 -28 weeks rapid gyral growth
bull Myelinization starts at 20 weeks gestation
continues for many years postnatally
bull 29-40 weeks 27 fold increase in brain volume
4 fold increase in grey matter volume
bull Brain folding coffee bean walnut
Gestational age are we always talking about
the same time
Pediatrics Vol 114 No 5 November 1 2004 pp 1362 -136 (4doi 101542peds2004-1915)
Estimate of gestational age
bull The best obstetric estimate is necessary
- gaps in obstetric information
- inherent variability (as great as 2 weeks) in traditional
methods of gestational age estimation
- postnatal physical examination inaccurate
bull First trimester ultrasound golden standard
(margin of error a few days)
bull Methods should be clearly stated
Wisserl J Et al Estimation of gestational age by transvaginal sonographic measurement of greatest embryonic length in
dated human embryos Ultrasound in Obstetrics amp Gynecology Volume 4 Issue 6 pages 457ndash462 1 November 1994
Bulletin of the World Health Organization The worldwide incidence of preterm birth a systematic review
of maternal mortality and morbidity Stacy Beck Daniel Wojdyla
Viability and its implications
bull Disability
bull Psychological bull emotional impact of raising a child with a disability
bull the child himself depression anxiety aggression lower self
concept (Rachel Levy Shifft and Gili Einat Journal of Clinical Child Psychology V 23 p 328-9)
bull Financial - US 2003
Premature newborns = US$181 billion in health care costs
= half of total hospital charges for newborn care
+ ongoing costs for the health system (14 billion on less of 125 USDday)
bull Societal
Thresholds of viability some numbers on
SURVIVALS
bull Dramatically improved during last 3 decades
bull Differences in methodology
bull Few studies have reported mortality and morbidity rates in gestational age-specific categories
Preterm Birth Causes Consequences and PreventionInstitute of Medicine (US) Committee on Understanding Premature
Birth and Assuring Healthy Outcomes Behrman RE Butler AS editorsWashington (DC) National Academies Press (US) 2007
Thresholds of viability some numbers on
SURVIVALS
ndash Risk of neonatal deaths not higher than 50 except for infants less
the 500g and 24 weeks gestation Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
ndash At 24 weeks survival = 58
ndash At 25 weeks = 77
ndash Not precised for lt 24 weeks
ndash Survival vary from 1 at 22 weeks to up to 44 at 25 weeks
ndash Before 21 weeks and six days no survival published
Brazier M et al Letting babies die J Med Ethics 2007 33 (3) 125-6
Thresholds of viability
bull Survival
ndash at 24 weeks 31
ndash at 25 weeks 50 Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
ndash at 23 and 24 weeks gestation varies from 10-50
ndash at 25 weeks gestation 50 - 80 Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
- 22w (0) 23w (29) 24w (50) 25w (65) Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely
preterm birth Keogh J et al Consensus Workshop Organising Committee
Thresholds of viability
bull gt 23 weeks gestation16 chance of surviving
bull At 24 weeks survival 44
bull At 25 weeks survival 63
bull Each day increases survival by 3
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity EPICure (UK Ireland)
bull Follow up of 78 of 308 children born lt 25 weeks + 6 days up to 6 years from 1995 on
bull 12 cerebral palsy bull lt 750g 30 - 50 moderate or severe disability
bull 41 cognitive problems (-2SD) compared to classmates
bull Survivers of 24 weeks 14 with no handicap
bull Survivers of 25 weeks 24 with no handicap
Marlow N Wolke D Bracewell MA Samara M The EPICure Study Group Neurologic disability at six years of age after
extremely preterm birth N Engl J Med 2005 352
EPICure
Morbidity EPIPAGE (France)
bull 77 of 2901 infants between 22 and 32 weeks
control group of term babies up to 5 years (not
finely sliced)
bull lt 27 weeks -1DS of QI attention deficit
language and behaviour disorders
Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
MorbidityThe American Academy of
Pediatrics
bull 30-50 of surviving children with lt750g or whose gestation lt25 weeks had moderate or severe disability
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
MorbidityNuffields (GB)
bull 23 - 24 weeks gestation 64 risk of serious disability
bull At 25 weeks risk of severe disability 40
bull Each day increases survival by 3
bull Girls have a weekrsquos advantage over preterm boys
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity Australia
bull Grey zone between 23-25 weeks + 6 days
bull Survival to discharge data
- 22w (0)
- 23w (29)
- 24w (50)
- 25w (65)
bull Proportion with no functional disability
23w (33) 24w (61) 25w (67)
Morbidity The Netherlands
Leiden follow up project data since 1983
Death or abnormal development
23-24 wks (92)
25 weeks (64)
26 weeks (35)
27-32 weeks (18)
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Rijken M et al Mortality and Neurologic Mental and Psychomotor Development at 2 Years in Infants Born less than 27 Weeks
Gestation The Leiden Follow-Up Project on Prematurity Pediatrics january 2003
Recommendations British Association of
Perinatal Medicine
22-28 weeks threshold of viability (under 26 weeks)
- Increasing risk with decreasing gestational age
serious ethical dilemmas
- Short notice decisions
- Need to balance maternal well-being against the
likely neonatal outcome
- Caesarean section in the babyrsquos interests
can rarely be justified prior to 25 weeks gestation
- Threshold viability infants should be followed up for
at least 2 years data collection
British Association of Perinatal Medicine Fetuses and newborn infants at the threshold of viability Pediatr 20021101024-27
Recommendations The American Academy
of Pediatrics bull 22-25 weeks gestation problematic
bull Non-initiation of resuscitation at 23 weeks (less 400g)
is appropriate
bull Difficulties in making accurate assessments before birth
bull Fetal weight can be inaccurate by 15-20
bull Small discrepancies in gestation of 1 or 2 weeks can have
major implications for outcome
bull Multiple gestation makes evaluation difficult
bull Counselling
bull But US legal trends restrict discretionary decision-making
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
The Marginally Viable Newborn Legal Challenges Conceptual Inadequacies and ReasonablenessSadath A Sayeed MD JD
The Journal of Law Medicine amp Ethics Volume 34 Issue 3 600-610 2006
Recommendations The Fetus and Newborn
Committee Canada
bull 22 weeks compassionate care only
bull 23-24 weeks careful consideration limited benefits and potential
harms of caesarean section and active resuscitation
bull Full care 25 weeks (survival rate is 50-80 with disability rates 10-25)
Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
What are ethics
bull ldquoNothing is either good or bad but thinking makes
it sordquo (W Shakespearersquos Hamlet)
bull Branch of philosophy addresses questions about
morality = concepts such as good and bad right
and wrong justice and virtue
bull The study of the general nature of morals and of
the specific moral choices to be made by a person
or a profession
Are ethical choices in medicine easy to
define
bull Classical medical ethical convictions
Preserve life - at any cost
bull Life or death = all or nothing = 100 or 0
bull At the threshold of viability in preterm
babies ldquoin-between statusrdquo prognosis quod
valitudinem difficult to predict
Definition of ethical choices in medicine
bull Beneficence best interest of the patient (Salus aegroti suprema lex)
bull Non-maleficence first do no harm (primum non nocere)
bull Autonomy the patient has the right to refuse or choose his treatment
(Voluntas aegroti suprema lex)
bull Justice distribution of scarce health resources decision of who gets
what treatment
bull Dignity the patient (and the person treating the patient) have the right
to dignity
bull Truthfulness
bull Honesty
Ethics in neonatology influenced byhellip
bull Culture - religion - philosophy
bull Sociology - society
bull Individual convictions
bull Cost
bull Fears dilemmas taboos
bull Juridical backgrounds
Singh M Ethical and social issues in the care of the newborn Indian J Pediatr May 200370(5)417-20
Ethics in neonatology
- We touch the most profound interface between
materialistic objective medicine and emotional
empathy personal conviction
- Tragic situations leave only tragic options
bull Skin immaturity
bull Fluid balance instability
bull Lung immaturity and breathing problems
bull Malnutrition and gut damage
bull Retinopathy of prematurity
bull Early and late onset infections
bull Brain damage which can lead to a spectrum of long-term
neurological sequelae = THE MAIN ETHICAL ISSUE
ldquoIn Preemies Better Care Also Means Hard Choicerdquo (New York Times August 13 2012)
Where do we touch the limits
Brain development
bull 12-16 weeks neuronal proliferation
bull 12 - 20 weeks neuronal migration
bull 20 weeks neuronal organisation inside-out layering
of the cortical neurones synaptogenesis
bull 26 -28 weeks rapid gyral growth
bull Myelinization starts at 20 weeks gestation
continues for many years postnatally
bull 29-40 weeks 27 fold increase in brain volume
4 fold increase in grey matter volume
bull Brain folding coffee bean walnut
Gestational age are we always talking about
the same time
Pediatrics Vol 114 No 5 November 1 2004 pp 1362 -136 (4doi 101542peds2004-1915)
Estimate of gestational age
bull The best obstetric estimate is necessary
- gaps in obstetric information
- inherent variability (as great as 2 weeks) in traditional
methods of gestational age estimation
- postnatal physical examination inaccurate
bull First trimester ultrasound golden standard
(margin of error a few days)
bull Methods should be clearly stated
Wisserl J Et al Estimation of gestational age by transvaginal sonographic measurement of greatest embryonic length in
dated human embryos Ultrasound in Obstetrics amp Gynecology Volume 4 Issue 6 pages 457ndash462 1 November 1994
Bulletin of the World Health Organization The worldwide incidence of preterm birth a systematic review
of maternal mortality and morbidity Stacy Beck Daniel Wojdyla
Viability and its implications
bull Disability
bull Psychological bull emotional impact of raising a child with a disability
bull the child himself depression anxiety aggression lower self
concept (Rachel Levy Shifft and Gili Einat Journal of Clinical Child Psychology V 23 p 328-9)
bull Financial - US 2003
Premature newborns = US$181 billion in health care costs
= half of total hospital charges for newborn care
+ ongoing costs for the health system (14 billion on less of 125 USDday)
bull Societal
Thresholds of viability some numbers on
SURVIVALS
bull Dramatically improved during last 3 decades
bull Differences in methodology
bull Few studies have reported mortality and morbidity rates in gestational age-specific categories
Preterm Birth Causes Consequences and PreventionInstitute of Medicine (US) Committee on Understanding Premature
Birth and Assuring Healthy Outcomes Behrman RE Butler AS editorsWashington (DC) National Academies Press (US) 2007
Thresholds of viability some numbers on
SURVIVALS
ndash Risk of neonatal deaths not higher than 50 except for infants less
the 500g and 24 weeks gestation Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
ndash At 24 weeks survival = 58
ndash At 25 weeks = 77
ndash Not precised for lt 24 weeks
ndash Survival vary from 1 at 22 weeks to up to 44 at 25 weeks
ndash Before 21 weeks and six days no survival published
Brazier M et al Letting babies die J Med Ethics 2007 33 (3) 125-6
Thresholds of viability
bull Survival
ndash at 24 weeks 31
ndash at 25 weeks 50 Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
ndash at 23 and 24 weeks gestation varies from 10-50
ndash at 25 weeks gestation 50 - 80 Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
- 22w (0) 23w (29) 24w (50) 25w (65) Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely
preterm birth Keogh J et al Consensus Workshop Organising Committee
Thresholds of viability
bull gt 23 weeks gestation16 chance of surviving
bull At 24 weeks survival 44
bull At 25 weeks survival 63
bull Each day increases survival by 3
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity EPICure (UK Ireland)
bull Follow up of 78 of 308 children born lt 25 weeks + 6 days up to 6 years from 1995 on
bull 12 cerebral palsy bull lt 750g 30 - 50 moderate or severe disability
bull 41 cognitive problems (-2SD) compared to classmates
bull Survivers of 24 weeks 14 with no handicap
bull Survivers of 25 weeks 24 with no handicap
Marlow N Wolke D Bracewell MA Samara M The EPICure Study Group Neurologic disability at six years of age after
extremely preterm birth N Engl J Med 2005 352
EPICure
Morbidity EPIPAGE (France)
bull 77 of 2901 infants between 22 and 32 weeks
control group of term babies up to 5 years (not
finely sliced)
bull lt 27 weeks -1DS of QI attention deficit
language and behaviour disorders
Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
MorbidityThe American Academy of
Pediatrics
bull 30-50 of surviving children with lt750g or whose gestation lt25 weeks had moderate or severe disability
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
MorbidityNuffields (GB)
bull 23 - 24 weeks gestation 64 risk of serious disability
bull At 25 weeks risk of severe disability 40
bull Each day increases survival by 3
bull Girls have a weekrsquos advantage over preterm boys
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity Australia
bull Grey zone between 23-25 weeks + 6 days
bull Survival to discharge data
- 22w (0)
- 23w (29)
- 24w (50)
- 25w (65)
bull Proportion with no functional disability
23w (33) 24w (61) 25w (67)
Morbidity The Netherlands
Leiden follow up project data since 1983
Death or abnormal development
23-24 wks (92)
25 weeks (64)
26 weeks (35)
27-32 weeks (18)
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Rijken M et al Mortality and Neurologic Mental and Psychomotor Development at 2 Years in Infants Born less than 27 Weeks
Gestation The Leiden Follow-Up Project on Prematurity Pediatrics january 2003
Recommendations British Association of
Perinatal Medicine
22-28 weeks threshold of viability (under 26 weeks)
- Increasing risk with decreasing gestational age
serious ethical dilemmas
- Short notice decisions
- Need to balance maternal well-being against the
likely neonatal outcome
- Caesarean section in the babyrsquos interests
can rarely be justified prior to 25 weeks gestation
- Threshold viability infants should be followed up for
at least 2 years data collection
British Association of Perinatal Medicine Fetuses and newborn infants at the threshold of viability Pediatr 20021101024-27
Recommendations The American Academy
of Pediatrics bull 22-25 weeks gestation problematic
bull Non-initiation of resuscitation at 23 weeks (less 400g)
is appropriate
bull Difficulties in making accurate assessments before birth
bull Fetal weight can be inaccurate by 15-20
bull Small discrepancies in gestation of 1 or 2 weeks can have
major implications for outcome
bull Multiple gestation makes evaluation difficult
bull Counselling
bull But US legal trends restrict discretionary decision-making
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
The Marginally Viable Newborn Legal Challenges Conceptual Inadequacies and ReasonablenessSadath A Sayeed MD JD
The Journal of Law Medicine amp Ethics Volume 34 Issue 3 600-610 2006
Recommendations The Fetus and Newborn
Committee Canada
bull 22 weeks compassionate care only
bull 23-24 weeks careful consideration limited benefits and potential
harms of caesarean section and active resuscitation
bull Full care 25 weeks (survival rate is 50-80 with disability rates 10-25)
Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Are ethical choices in medicine easy to
define
bull Classical medical ethical convictions
Preserve life - at any cost
bull Life or death = all or nothing = 100 or 0
bull At the threshold of viability in preterm
babies ldquoin-between statusrdquo prognosis quod
valitudinem difficult to predict
Definition of ethical choices in medicine
bull Beneficence best interest of the patient (Salus aegroti suprema lex)
bull Non-maleficence first do no harm (primum non nocere)
bull Autonomy the patient has the right to refuse or choose his treatment
(Voluntas aegroti suprema lex)
bull Justice distribution of scarce health resources decision of who gets
what treatment
bull Dignity the patient (and the person treating the patient) have the right
to dignity
bull Truthfulness
bull Honesty
Ethics in neonatology influenced byhellip
bull Culture - religion - philosophy
bull Sociology - society
bull Individual convictions
bull Cost
bull Fears dilemmas taboos
bull Juridical backgrounds
Singh M Ethical and social issues in the care of the newborn Indian J Pediatr May 200370(5)417-20
Ethics in neonatology
- We touch the most profound interface between
materialistic objective medicine and emotional
empathy personal conviction
- Tragic situations leave only tragic options
bull Skin immaturity
bull Fluid balance instability
bull Lung immaturity and breathing problems
bull Malnutrition and gut damage
bull Retinopathy of prematurity
bull Early and late onset infections
bull Brain damage which can lead to a spectrum of long-term
neurological sequelae = THE MAIN ETHICAL ISSUE
ldquoIn Preemies Better Care Also Means Hard Choicerdquo (New York Times August 13 2012)
Where do we touch the limits
Brain development
bull 12-16 weeks neuronal proliferation
bull 12 - 20 weeks neuronal migration
bull 20 weeks neuronal organisation inside-out layering
of the cortical neurones synaptogenesis
bull 26 -28 weeks rapid gyral growth
bull Myelinization starts at 20 weeks gestation
continues for many years postnatally
bull 29-40 weeks 27 fold increase in brain volume
4 fold increase in grey matter volume
bull Brain folding coffee bean walnut
Gestational age are we always talking about
the same time
Pediatrics Vol 114 No 5 November 1 2004 pp 1362 -136 (4doi 101542peds2004-1915)
Estimate of gestational age
bull The best obstetric estimate is necessary
- gaps in obstetric information
- inherent variability (as great as 2 weeks) in traditional
methods of gestational age estimation
- postnatal physical examination inaccurate
bull First trimester ultrasound golden standard
(margin of error a few days)
bull Methods should be clearly stated
Wisserl J Et al Estimation of gestational age by transvaginal sonographic measurement of greatest embryonic length in
dated human embryos Ultrasound in Obstetrics amp Gynecology Volume 4 Issue 6 pages 457ndash462 1 November 1994
Bulletin of the World Health Organization The worldwide incidence of preterm birth a systematic review
of maternal mortality and morbidity Stacy Beck Daniel Wojdyla
Viability and its implications
bull Disability
bull Psychological bull emotional impact of raising a child with a disability
bull the child himself depression anxiety aggression lower self
concept (Rachel Levy Shifft and Gili Einat Journal of Clinical Child Psychology V 23 p 328-9)
bull Financial - US 2003
Premature newborns = US$181 billion in health care costs
= half of total hospital charges for newborn care
+ ongoing costs for the health system (14 billion on less of 125 USDday)
bull Societal
Thresholds of viability some numbers on
SURVIVALS
bull Dramatically improved during last 3 decades
bull Differences in methodology
bull Few studies have reported mortality and morbidity rates in gestational age-specific categories
Preterm Birth Causes Consequences and PreventionInstitute of Medicine (US) Committee on Understanding Premature
Birth and Assuring Healthy Outcomes Behrman RE Butler AS editorsWashington (DC) National Academies Press (US) 2007
Thresholds of viability some numbers on
SURVIVALS
ndash Risk of neonatal deaths not higher than 50 except for infants less
the 500g and 24 weeks gestation Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
ndash At 24 weeks survival = 58
ndash At 25 weeks = 77
ndash Not precised for lt 24 weeks
ndash Survival vary from 1 at 22 weeks to up to 44 at 25 weeks
ndash Before 21 weeks and six days no survival published
Brazier M et al Letting babies die J Med Ethics 2007 33 (3) 125-6
Thresholds of viability
bull Survival
ndash at 24 weeks 31
ndash at 25 weeks 50 Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
ndash at 23 and 24 weeks gestation varies from 10-50
ndash at 25 weeks gestation 50 - 80 Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
- 22w (0) 23w (29) 24w (50) 25w (65) Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely
preterm birth Keogh J et al Consensus Workshop Organising Committee
Thresholds of viability
bull gt 23 weeks gestation16 chance of surviving
bull At 24 weeks survival 44
bull At 25 weeks survival 63
bull Each day increases survival by 3
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity EPICure (UK Ireland)
bull Follow up of 78 of 308 children born lt 25 weeks + 6 days up to 6 years from 1995 on
bull 12 cerebral palsy bull lt 750g 30 - 50 moderate or severe disability
bull 41 cognitive problems (-2SD) compared to classmates
bull Survivers of 24 weeks 14 with no handicap
bull Survivers of 25 weeks 24 with no handicap
Marlow N Wolke D Bracewell MA Samara M The EPICure Study Group Neurologic disability at six years of age after
extremely preterm birth N Engl J Med 2005 352
EPICure
Morbidity EPIPAGE (France)
bull 77 of 2901 infants between 22 and 32 weeks
control group of term babies up to 5 years (not
finely sliced)
bull lt 27 weeks -1DS of QI attention deficit
language and behaviour disorders
Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
MorbidityThe American Academy of
Pediatrics
bull 30-50 of surviving children with lt750g or whose gestation lt25 weeks had moderate or severe disability
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
MorbidityNuffields (GB)
bull 23 - 24 weeks gestation 64 risk of serious disability
bull At 25 weeks risk of severe disability 40
bull Each day increases survival by 3
bull Girls have a weekrsquos advantage over preterm boys
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity Australia
bull Grey zone between 23-25 weeks + 6 days
bull Survival to discharge data
- 22w (0)
- 23w (29)
- 24w (50)
- 25w (65)
bull Proportion with no functional disability
23w (33) 24w (61) 25w (67)
Morbidity The Netherlands
Leiden follow up project data since 1983
Death or abnormal development
23-24 wks (92)
25 weeks (64)
26 weeks (35)
27-32 weeks (18)
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Rijken M et al Mortality and Neurologic Mental and Psychomotor Development at 2 Years in Infants Born less than 27 Weeks
Gestation The Leiden Follow-Up Project on Prematurity Pediatrics january 2003
Recommendations British Association of
Perinatal Medicine
22-28 weeks threshold of viability (under 26 weeks)
- Increasing risk with decreasing gestational age
serious ethical dilemmas
- Short notice decisions
- Need to balance maternal well-being against the
likely neonatal outcome
- Caesarean section in the babyrsquos interests
can rarely be justified prior to 25 weeks gestation
- Threshold viability infants should be followed up for
at least 2 years data collection
British Association of Perinatal Medicine Fetuses and newborn infants at the threshold of viability Pediatr 20021101024-27
Recommendations The American Academy
of Pediatrics bull 22-25 weeks gestation problematic
bull Non-initiation of resuscitation at 23 weeks (less 400g)
is appropriate
bull Difficulties in making accurate assessments before birth
bull Fetal weight can be inaccurate by 15-20
bull Small discrepancies in gestation of 1 or 2 weeks can have
major implications for outcome
bull Multiple gestation makes evaluation difficult
bull Counselling
bull But US legal trends restrict discretionary decision-making
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
The Marginally Viable Newborn Legal Challenges Conceptual Inadequacies and ReasonablenessSadath A Sayeed MD JD
The Journal of Law Medicine amp Ethics Volume 34 Issue 3 600-610 2006
Recommendations The Fetus and Newborn
Committee Canada
bull 22 weeks compassionate care only
bull 23-24 weeks careful consideration limited benefits and potential
harms of caesarean section and active resuscitation
bull Full care 25 weeks (survival rate is 50-80 with disability rates 10-25)
Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Definition of ethical choices in medicine
bull Beneficence best interest of the patient (Salus aegroti suprema lex)
bull Non-maleficence first do no harm (primum non nocere)
bull Autonomy the patient has the right to refuse or choose his treatment
(Voluntas aegroti suprema lex)
bull Justice distribution of scarce health resources decision of who gets
what treatment
bull Dignity the patient (and the person treating the patient) have the right
to dignity
bull Truthfulness
bull Honesty
Ethics in neonatology influenced byhellip
bull Culture - religion - philosophy
bull Sociology - society
bull Individual convictions
bull Cost
bull Fears dilemmas taboos
bull Juridical backgrounds
Singh M Ethical and social issues in the care of the newborn Indian J Pediatr May 200370(5)417-20
Ethics in neonatology
- We touch the most profound interface between
materialistic objective medicine and emotional
empathy personal conviction
- Tragic situations leave only tragic options
bull Skin immaturity
bull Fluid balance instability
bull Lung immaturity and breathing problems
bull Malnutrition and gut damage
bull Retinopathy of prematurity
bull Early and late onset infections
bull Brain damage which can lead to a spectrum of long-term
neurological sequelae = THE MAIN ETHICAL ISSUE
ldquoIn Preemies Better Care Also Means Hard Choicerdquo (New York Times August 13 2012)
Where do we touch the limits
Brain development
bull 12-16 weeks neuronal proliferation
bull 12 - 20 weeks neuronal migration
bull 20 weeks neuronal organisation inside-out layering
of the cortical neurones synaptogenesis
bull 26 -28 weeks rapid gyral growth
bull Myelinization starts at 20 weeks gestation
continues for many years postnatally
bull 29-40 weeks 27 fold increase in brain volume
4 fold increase in grey matter volume
bull Brain folding coffee bean walnut
Gestational age are we always talking about
the same time
Pediatrics Vol 114 No 5 November 1 2004 pp 1362 -136 (4doi 101542peds2004-1915)
Estimate of gestational age
bull The best obstetric estimate is necessary
- gaps in obstetric information
- inherent variability (as great as 2 weeks) in traditional
methods of gestational age estimation
- postnatal physical examination inaccurate
bull First trimester ultrasound golden standard
(margin of error a few days)
bull Methods should be clearly stated
Wisserl J Et al Estimation of gestational age by transvaginal sonographic measurement of greatest embryonic length in
dated human embryos Ultrasound in Obstetrics amp Gynecology Volume 4 Issue 6 pages 457ndash462 1 November 1994
Bulletin of the World Health Organization The worldwide incidence of preterm birth a systematic review
of maternal mortality and morbidity Stacy Beck Daniel Wojdyla
Viability and its implications
bull Disability
bull Psychological bull emotional impact of raising a child with a disability
bull the child himself depression anxiety aggression lower self
concept (Rachel Levy Shifft and Gili Einat Journal of Clinical Child Psychology V 23 p 328-9)
bull Financial - US 2003
Premature newborns = US$181 billion in health care costs
= half of total hospital charges for newborn care
+ ongoing costs for the health system (14 billion on less of 125 USDday)
bull Societal
Thresholds of viability some numbers on
SURVIVALS
bull Dramatically improved during last 3 decades
bull Differences in methodology
bull Few studies have reported mortality and morbidity rates in gestational age-specific categories
Preterm Birth Causes Consequences and PreventionInstitute of Medicine (US) Committee on Understanding Premature
Birth and Assuring Healthy Outcomes Behrman RE Butler AS editorsWashington (DC) National Academies Press (US) 2007
Thresholds of viability some numbers on
SURVIVALS
ndash Risk of neonatal deaths not higher than 50 except for infants less
the 500g and 24 weeks gestation Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
ndash At 24 weeks survival = 58
ndash At 25 weeks = 77
ndash Not precised for lt 24 weeks
ndash Survival vary from 1 at 22 weeks to up to 44 at 25 weeks
ndash Before 21 weeks and six days no survival published
Brazier M et al Letting babies die J Med Ethics 2007 33 (3) 125-6
Thresholds of viability
bull Survival
ndash at 24 weeks 31
ndash at 25 weeks 50 Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
ndash at 23 and 24 weeks gestation varies from 10-50
ndash at 25 weeks gestation 50 - 80 Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
- 22w (0) 23w (29) 24w (50) 25w (65) Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely
preterm birth Keogh J et al Consensus Workshop Organising Committee
Thresholds of viability
bull gt 23 weeks gestation16 chance of surviving
bull At 24 weeks survival 44
bull At 25 weeks survival 63
bull Each day increases survival by 3
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity EPICure (UK Ireland)
bull Follow up of 78 of 308 children born lt 25 weeks + 6 days up to 6 years from 1995 on
bull 12 cerebral palsy bull lt 750g 30 - 50 moderate or severe disability
bull 41 cognitive problems (-2SD) compared to classmates
bull Survivers of 24 weeks 14 with no handicap
bull Survivers of 25 weeks 24 with no handicap
Marlow N Wolke D Bracewell MA Samara M The EPICure Study Group Neurologic disability at six years of age after
extremely preterm birth N Engl J Med 2005 352
EPICure
Morbidity EPIPAGE (France)
bull 77 of 2901 infants between 22 and 32 weeks
control group of term babies up to 5 years (not
finely sliced)
bull lt 27 weeks -1DS of QI attention deficit
language and behaviour disorders
Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
MorbidityThe American Academy of
Pediatrics
bull 30-50 of surviving children with lt750g or whose gestation lt25 weeks had moderate or severe disability
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
MorbidityNuffields (GB)
bull 23 - 24 weeks gestation 64 risk of serious disability
bull At 25 weeks risk of severe disability 40
bull Each day increases survival by 3
bull Girls have a weekrsquos advantage over preterm boys
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity Australia
bull Grey zone between 23-25 weeks + 6 days
bull Survival to discharge data
- 22w (0)
- 23w (29)
- 24w (50)
- 25w (65)
bull Proportion with no functional disability
23w (33) 24w (61) 25w (67)
Morbidity The Netherlands
Leiden follow up project data since 1983
Death or abnormal development
23-24 wks (92)
25 weeks (64)
26 weeks (35)
27-32 weeks (18)
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Rijken M et al Mortality and Neurologic Mental and Psychomotor Development at 2 Years in Infants Born less than 27 Weeks
Gestation The Leiden Follow-Up Project on Prematurity Pediatrics january 2003
Recommendations British Association of
Perinatal Medicine
22-28 weeks threshold of viability (under 26 weeks)
- Increasing risk with decreasing gestational age
serious ethical dilemmas
- Short notice decisions
- Need to balance maternal well-being against the
likely neonatal outcome
- Caesarean section in the babyrsquos interests
can rarely be justified prior to 25 weeks gestation
- Threshold viability infants should be followed up for
at least 2 years data collection
British Association of Perinatal Medicine Fetuses and newborn infants at the threshold of viability Pediatr 20021101024-27
Recommendations The American Academy
of Pediatrics bull 22-25 weeks gestation problematic
bull Non-initiation of resuscitation at 23 weeks (less 400g)
is appropriate
bull Difficulties in making accurate assessments before birth
bull Fetal weight can be inaccurate by 15-20
bull Small discrepancies in gestation of 1 or 2 weeks can have
major implications for outcome
bull Multiple gestation makes evaluation difficult
bull Counselling
bull But US legal trends restrict discretionary decision-making
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
The Marginally Viable Newborn Legal Challenges Conceptual Inadequacies and ReasonablenessSadath A Sayeed MD JD
The Journal of Law Medicine amp Ethics Volume 34 Issue 3 600-610 2006
Recommendations The Fetus and Newborn
Committee Canada
bull 22 weeks compassionate care only
bull 23-24 weeks careful consideration limited benefits and potential
harms of caesarean section and active resuscitation
bull Full care 25 weeks (survival rate is 50-80 with disability rates 10-25)
Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Ethics in neonatology influenced byhellip
bull Culture - religion - philosophy
bull Sociology - society
bull Individual convictions
bull Cost
bull Fears dilemmas taboos
bull Juridical backgrounds
Singh M Ethical and social issues in the care of the newborn Indian J Pediatr May 200370(5)417-20
Ethics in neonatology
- We touch the most profound interface between
materialistic objective medicine and emotional
empathy personal conviction
- Tragic situations leave only tragic options
bull Skin immaturity
bull Fluid balance instability
bull Lung immaturity and breathing problems
bull Malnutrition and gut damage
bull Retinopathy of prematurity
bull Early and late onset infections
bull Brain damage which can lead to a spectrum of long-term
neurological sequelae = THE MAIN ETHICAL ISSUE
ldquoIn Preemies Better Care Also Means Hard Choicerdquo (New York Times August 13 2012)
Where do we touch the limits
Brain development
bull 12-16 weeks neuronal proliferation
bull 12 - 20 weeks neuronal migration
bull 20 weeks neuronal organisation inside-out layering
of the cortical neurones synaptogenesis
bull 26 -28 weeks rapid gyral growth
bull Myelinization starts at 20 weeks gestation
continues for many years postnatally
bull 29-40 weeks 27 fold increase in brain volume
4 fold increase in grey matter volume
bull Brain folding coffee bean walnut
Gestational age are we always talking about
the same time
Pediatrics Vol 114 No 5 November 1 2004 pp 1362 -136 (4doi 101542peds2004-1915)
Estimate of gestational age
bull The best obstetric estimate is necessary
- gaps in obstetric information
- inherent variability (as great as 2 weeks) in traditional
methods of gestational age estimation
- postnatal physical examination inaccurate
bull First trimester ultrasound golden standard
(margin of error a few days)
bull Methods should be clearly stated
Wisserl J Et al Estimation of gestational age by transvaginal sonographic measurement of greatest embryonic length in
dated human embryos Ultrasound in Obstetrics amp Gynecology Volume 4 Issue 6 pages 457ndash462 1 November 1994
Bulletin of the World Health Organization The worldwide incidence of preterm birth a systematic review
of maternal mortality and morbidity Stacy Beck Daniel Wojdyla
Viability and its implications
bull Disability
bull Psychological bull emotional impact of raising a child with a disability
bull the child himself depression anxiety aggression lower self
concept (Rachel Levy Shifft and Gili Einat Journal of Clinical Child Psychology V 23 p 328-9)
bull Financial - US 2003
Premature newborns = US$181 billion in health care costs
= half of total hospital charges for newborn care
+ ongoing costs for the health system (14 billion on less of 125 USDday)
bull Societal
Thresholds of viability some numbers on
SURVIVALS
bull Dramatically improved during last 3 decades
bull Differences in methodology
bull Few studies have reported mortality and morbidity rates in gestational age-specific categories
Preterm Birth Causes Consequences and PreventionInstitute of Medicine (US) Committee on Understanding Premature
Birth and Assuring Healthy Outcomes Behrman RE Butler AS editorsWashington (DC) National Academies Press (US) 2007
Thresholds of viability some numbers on
SURVIVALS
ndash Risk of neonatal deaths not higher than 50 except for infants less
the 500g and 24 weeks gestation Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
ndash At 24 weeks survival = 58
ndash At 25 weeks = 77
ndash Not precised for lt 24 weeks
ndash Survival vary from 1 at 22 weeks to up to 44 at 25 weeks
ndash Before 21 weeks and six days no survival published
Brazier M et al Letting babies die J Med Ethics 2007 33 (3) 125-6
Thresholds of viability
bull Survival
ndash at 24 weeks 31
ndash at 25 weeks 50 Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
ndash at 23 and 24 weeks gestation varies from 10-50
ndash at 25 weeks gestation 50 - 80 Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
- 22w (0) 23w (29) 24w (50) 25w (65) Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely
preterm birth Keogh J et al Consensus Workshop Organising Committee
Thresholds of viability
bull gt 23 weeks gestation16 chance of surviving
bull At 24 weeks survival 44
bull At 25 weeks survival 63
bull Each day increases survival by 3
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity EPICure (UK Ireland)
bull Follow up of 78 of 308 children born lt 25 weeks + 6 days up to 6 years from 1995 on
bull 12 cerebral palsy bull lt 750g 30 - 50 moderate or severe disability
bull 41 cognitive problems (-2SD) compared to classmates
bull Survivers of 24 weeks 14 with no handicap
bull Survivers of 25 weeks 24 with no handicap
Marlow N Wolke D Bracewell MA Samara M The EPICure Study Group Neurologic disability at six years of age after
extremely preterm birth N Engl J Med 2005 352
EPICure
Morbidity EPIPAGE (France)
bull 77 of 2901 infants between 22 and 32 weeks
control group of term babies up to 5 years (not
finely sliced)
bull lt 27 weeks -1DS of QI attention deficit
language and behaviour disorders
Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
MorbidityThe American Academy of
Pediatrics
bull 30-50 of surviving children with lt750g or whose gestation lt25 weeks had moderate or severe disability
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
MorbidityNuffields (GB)
bull 23 - 24 weeks gestation 64 risk of serious disability
bull At 25 weeks risk of severe disability 40
bull Each day increases survival by 3
bull Girls have a weekrsquos advantage over preterm boys
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity Australia
bull Grey zone between 23-25 weeks + 6 days
bull Survival to discharge data
- 22w (0)
- 23w (29)
- 24w (50)
- 25w (65)
bull Proportion with no functional disability
23w (33) 24w (61) 25w (67)
Morbidity The Netherlands
Leiden follow up project data since 1983
Death or abnormal development
23-24 wks (92)
25 weeks (64)
26 weeks (35)
27-32 weeks (18)
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Rijken M et al Mortality and Neurologic Mental and Psychomotor Development at 2 Years in Infants Born less than 27 Weeks
Gestation The Leiden Follow-Up Project on Prematurity Pediatrics january 2003
Recommendations British Association of
Perinatal Medicine
22-28 weeks threshold of viability (under 26 weeks)
- Increasing risk with decreasing gestational age
serious ethical dilemmas
- Short notice decisions
- Need to balance maternal well-being against the
likely neonatal outcome
- Caesarean section in the babyrsquos interests
can rarely be justified prior to 25 weeks gestation
- Threshold viability infants should be followed up for
at least 2 years data collection
British Association of Perinatal Medicine Fetuses and newborn infants at the threshold of viability Pediatr 20021101024-27
Recommendations The American Academy
of Pediatrics bull 22-25 weeks gestation problematic
bull Non-initiation of resuscitation at 23 weeks (less 400g)
is appropriate
bull Difficulties in making accurate assessments before birth
bull Fetal weight can be inaccurate by 15-20
bull Small discrepancies in gestation of 1 or 2 weeks can have
major implications for outcome
bull Multiple gestation makes evaluation difficult
bull Counselling
bull But US legal trends restrict discretionary decision-making
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
The Marginally Viable Newborn Legal Challenges Conceptual Inadequacies and ReasonablenessSadath A Sayeed MD JD
The Journal of Law Medicine amp Ethics Volume 34 Issue 3 600-610 2006
Recommendations The Fetus and Newborn
Committee Canada
bull 22 weeks compassionate care only
bull 23-24 weeks careful consideration limited benefits and potential
harms of caesarean section and active resuscitation
bull Full care 25 weeks (survival rate is 50-80 with disability rates 10-25)
Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Ethics in neonatology
- We touch the most profound interface between
materialistic objective medicine and emotional
empathy personal conviction
- Tragic situations leave only tragic options
bull Skin immaturity
bull Fluid balance instability
bull Lung immaturity and breathing problems
bull Malnutrition and gut damage
bull Retinopathy of prematurity
bull Early and late onset infections
bull Brain damage which can lead to a spectrum of long-term
neurological sequelae = THE MAIN ETHICAL ISSUE
ldquoIn Preemies Better Care Also Means Hard Choicerdquo (New York Times August 13 2012)
Where do we touch the limits
Brain development
bull 12-16 weeks neuronal proliferation
bull 12 - 20 weeks neuronal migration
bull 20 weeks neuronal organisation inside-out layering
of the cortical neurones synaptogenesis
bull 26 -28 weeks rapid gyral growth
bull Myelinization starts at 20 weeks gestation
continues for many years postnatally
bull 29-40 weeks 27 fold increase in brain volume
4 fold increase in grey matter volume
bull Brain folding coffee bean walnut
Gestational age are we always talking about
the same time
Pediatrics Vol 114 No 5 November 1 2004 pp 1362 -136 (4doi 101542peds2004-1915)
Estimate of gestational age
bull The best obstetric estimate is necessary
- gaps in obstetric information
- inherent variability (as great as 2 weeks) in traditional
methods of gestational age estimation
- postnatal physical examination inaccurate
bull First trimester ultrasound golden standard
(margin of error a few days)
bull Methods should be clearly stated
Wisserl J Et al Estimation of gestational age by transvaginal sonographic measurement of greatest embryonic length in
dated human embryos Ultrasound in Obstetrics amp Gynecology Volume 4 Issue 6 pages 457ndash462 1 November 1994
Bulletin of the World Health Organization The worldwide incidence of preterm birth a systematic review
of maternal mortality and morbidity Stacy Beck Daniel Wojdyla
Viability and its implications
bull Disability
bull Psychological bull emotional impact of raising a child with a disability
bull the child himself depression anxiety aggression lower self
concept (Rachel Levy Shifft and Gili Einat Journal of Clinical Child Psychology V 23 p 328-9)
bull Financial - US 2003
Premature newborns = US$181 billion in health care costs
= half of total hospital charges for newborn care
+ ongoing costs for the health system (14 billion on less of 125 USDday)
bull Societal
Thresholds of viability some numbers on
SURVIVALS
bull Dramatically improved during last 3 decades
bull Differences in methodology
bull Few studies have reported mortality and morbidity rates in gestational age-specific categories
Preterm Birth Causes Consequences and PreventionInstitute of Medicine (US) Committee on Understanding Premature
Birth and Assuring Healthy Outcomes Behrman RE Butler AS editorsWashington (DC) National Academies Press (US) 2007
Thresholds of viability some numbers on
SURVIVALS
ndash Risk of neonatal deaths not higher than 50 except for infants less
the 500g and 24 weeks gestation Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
ndash At 24 weeks survival = 58
ndash At 25 weeks = 77
ndash Not precised for lt 24 weeks
ndash Survival vary from 1 at 22 weeks to up to 44 at 25 weeks
ndash Before 21 weeks and six days no survival published
Brazier M et al Letting babies die J Med Ethics 2007 33 (3) 125-6
Thresholds of viability
bull Survival
ndash at 24 weeks 31
ndash at 25 weeks 50 Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
ndash at 23 and 24 weeks gestation varies from 10-50
ndash at 25 weeks gestation 50 - 80 Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
- 22w (0) 23w (29) 24w (50) 25w (65) Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely
preterm birth Keogh J et al Consensus Workshop Organising Committee
Thresholds of viability
bull gt 23 weeks gestation16 chance of surviving
bull At 24 weeks survival 44
bull At 25 weeks survival 63
bull Each day increases survival by 3
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity EPICure (UK Ireland)
bull Follow up of 78 of 308 children born lt 25 weeks + 6 days up to 6 years from 1995 on
bull 12 cerebral palsy bull lt 750g 30 - 50 moderate or severe disability
bull 41 cognitive problems (-2SD) compared to classmates
bull Survivers of 24 weeks 14 with no handicap
bull Survivers of 25 weeks 24 with no handicap
Marlow N Wolke D Bracewell MA Samara M The EPICure Study Group Neurologic disability at six years of age after
extremely preterm birth N Engl J Med 2005 352
EPICure
Morbidity EPIPAGE (France)
bull 77 of 2901 infants between 22 and 32 weeks
control group of term babies up to 5 years (not
finely sliced)
bull lt 27 weeks -1DS of QI attention deficit
language and behaviour disorders
Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
MorbidityThe American Academy of
Pediatrics
bull 30-50 of surviving children with lt750g or whose gestation lt25 weeks had moderate or severe disability
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
MorbidityNuffields (GB)
bull 23 - 24 weeks gestation 64 risk of serious disability
bull At 25 weeks risk of severe disability 40
bull Each day increases survival by 3
bull Girls have a weekrsquos advantage over preterm boys
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity Australia
bull Grey zone between 23-25 weeks + 6 days
bull Survival to discharge data
- 22w (0)
- 23w (29)
- 24w (50)
- 25w (65)
bull Proportion with no functional disability
23w (33) 24w (61) 25w (67)
Morbidity The Netherlands
Leiden follow up project data since 1983
Death or abnormal development
23-24 wks (92)
25 weeks (64)
26 weeks (35)
27-32 weeks (18)
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Rijken M et al Mortality and Neurologic Mental and Psychomotor Development at 2 Years in Infants Born less than 27 Weeks
Gestation The Leiden Follow-Up Project on Prematurity Pediatrics january 2003
Recommendations British Association of
Perinatal Medicine
22-28 weeks threshold of viability (under 26 weeks)
- Increasing risk with decreasing gestational age
serious ethical dilemmas
- Short notice decisions
- Need to balance maternal well-being against the
likely neonatal outcome
- Caesarean section in the babyrsquos interests
can rarely be justified prior to 25 weeks gestation
- Threshold viability infants should be followed up for
at least 2 years data collection
British Association of Perinatal Medicine Fetuses and newborn infants at the threshold of viability Pediatr 20021101024-27
Recommendations The American Academy
of Pediatrics bull 22-25 weeks gestation problematic
bull Non-initiation of resuscitation at 23 weeks (less 400g)
is appropriate
bull Difficulties in making accurate assessments before birth
bull Fetal weight can be inaccurate by 15-20
bull Small discrepancies in gestation of 1 or 2 weeks can have
major implications for outcome
bull Multiple gestation makes evaluation difficult
bull Counselling
bull But US legal trends restrict discretionary decision-making
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
The Marginally Viable Newborn Legal Challenges Conceptual Inadequacies and ReasonablenessSadath A Sayeed MD JD
The Journal of Law Medicine amp Ethics Volume 34 Issue 3 600-610 2006
Recommendations The Fetus and Newborn
Committee Canada
bull 22 weeks compassionate care only
bull 23-24 weeks careful consideration limited benefits and potential
harms of caesarean section and active resuscitation
bull Full care 25 weeks (survival rate is 50-80 with disability rates 10-25)
Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
bull Skin immaturity
bull Fluid balance instability
bull Lung immaturity and breathing problems
bull Malnutrition and gut damage
bull Retinopathy of prematurity
bull Early and late onset infections
bull Brain damage which can lead to a spectrum of long-term
neurological sequelae = THE MAIN ETHICAL ISSUE
ldquoIn Preemies Better Care Also Means Hard Choicerdquo (New York Times August 13 2012)
Where do we touch the limits
Brain development
bull 12-16 weeks neuronal proliferation
bull 12 - 20 weeks neuronal migration
bull 20 weeks neuronal organisation inside-out layering
of the cortical neurones synaptogenesis
bull 26 -28 weeks rapid gyral growth
bull Myelinization starts at 20 weeks gestation
continues for many years postnatally
bull 29-40 weeks 27 fold increase in brain volume
4 fold increase in grey matter volume
bull Brain folding coffee bean walnut
Gestational age are we always talking about
the same time
Pediatrics Vol 114 No 5 November 1 2004 pp 1362 -136 (4doi 101542peds2004-1915)
Estimate of gestational age
bull The best obstetric estimate is necessary
- gaps in obstetric information
- inherent variability (as great as 2 weeks) in traditional
methods of gestational age estimation
- postnatal physical examination inaccurate
bull First trimester ultrasound golden standard
(margin of error a few days)
bull Methods should be clearly stated
Wisserl J Et al Estimation of gestational age by transvaginal sonographic measurement of greatest embryonic length in
dated human embryos Ultrasound in Obstetrics amp Gynecology Volume 4 Issue 6 pages 457ndash462 1 November 1994
Bulletin of the World Health Organization The worldwide incidence of preterm birth a systematic review
of maternal mortality and morbidity Stacy Beck Daniel Wojdyla
Viability and its implications
bull Disability
bull Psychological bull emotional impact of raising a child with a disability
bull the child himself depression anxiety aggression lower self
concept (Rachel Levy Shifft and Gili Einat Journal of Clinical Child Psychology V 23 p 328-9)
bull Financial - US 2003
Premature newborns = US$181 billion in health care costs
= half of total hospital charges for newborn care
+ ongoing costs for the health system (14 billion on less of 125 USDday)
bull Societal
Thresholds of viability some numbers on
SURVIVALS
bull Dramatically improved during last 3 decades
bull Differences in methodology
bull Few studies have reported mortality and morbidity rates in gestational age-specific categories
Preterm Birth Causes Consequences and PreventionInstitute of Medicine (US) Committee on Understanding Premature
Birth and Assuring Healthy Outcomes Behrman RE Butler AS editorsWashington (DC) National Academies Press (US) 2007
Thresholds of viability some numbers on
SURVIVALS
ndash Risk of neonatal deaths not higher than 50 except for infants less
the 500g and 24 weeks gestation Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
ndash At 24 weeks survival = 58
ndash At 25 weeks = 77
ndash Not precised for lt 24 weeks
ndash Survival vary from 1 at 22 weeks to up to 44 at 25 weeks
ndash Before 21 weeks and six days no survival published
Brazier M et al Letting babies die J Med Ethics 2007 33 (3) 125-6
Thresholds of viability
bull Survival
ndash at 24 weeks 31
ndash at 25 weeks 50 Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
ndash at 23 and 24 weeks gestation varies from 10-50
ndash at 25 weeks gestation 50 - 80 Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
- 22w (0) 23w (29) 24w (50) 25w (65) Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely
preterm birth Keogh J et al Consensus Workshop Organising Committee
Thresholds of viability
bull gt 23 weeks gestation16 chance of surviving
bull At 24 weeks survival 44
bull At 25 weeks survival 63
bull Each day increases survival by 3
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity EPICure (UK Ireland)
bull Follow up of 78 of 308 children born lt 25 weeks + 6 days up to 6 years from 1995 on
bull 12 cerebral palsy bull lt 750g 30 - 50 moderate or severe disability
bull 41 cognitive problems (-2SD) compared to classmates
bull Survivers of 24 weeks 14 with no handicap
bull Survivers of 25 weeks 24 with no handicap
Marlow N Wolke D Bracewell MA Samara M The EPICure Study Group Neurologic disability at six years of age after
extremely preterm birth N Engl J Med 2005 352
EPICure
Morbidity EPIPAGE (France)
bull 77 of 2901 infants between 22 and 32 weeks
control group of term babies up to 5 years (not
finely sliced)
bull lt 27 weeks -1DS of QI attention deficit
language and behaviour disorders
Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
MorbidityThe American Academy of
Pediatrics
bull 30-50 of surviving children with lt750g or whose gestation lt25 weeks had moderate or severe disability
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
MorbidityNuffields (GB)
bull 23 - 24 weeks gestation 64 risk of serious disability
bull At 25 weeks risk of severe disability 40
bull Each day increases survival by 3
bull Girls have a weekrsquos advantage over preterm boys
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity Australia
bull Grey zone between 23-25 weeks + 6 days
bull Survival to discharge data
- 22w (0)
- 23w (29)
- 24w (50)
- 25w (65)
bull Proportion with no functional disability
23w (33) 24w (61) 25w (67)
Morbidity The Netherlands
Leiden follow up project data since 1983
Death or abnormal development
23-24 wks (92)
25 weeks (64)
26 weeks (35)
27-32 weeks (18)
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Rijken M et al Mortality and Neurologic Mental and Psychomotor Development at 2 Years in Infants Born less than 27 Weeks
Gestation The Leiden Follow-Up Project on Prematurity Pediatrics january 2003
Recommendations British Association of
Perinatal Medicine
22-28 weeks threshold of viability (under 26 weeks)
- Increasing risk with decreasing gestational age
serious ethical dilemmas
- Short notice decisions
- Need to balance maternal well-being against the
likely neonatal outcome
- Caesarean section in the babyrsquos interests
can rarely be justified prior to 25 weeks gestation
- Threshold viability infants should be followed up for
at least 2 years data collection
British Association of Perinatal Medicine Fetuses and newborn infants at the threshold of viability Pediatr 20021101024-27
Recommendations The American Academy
of Pediatrics bull 22-25 weeks gestation problematic
bull Non-initiation of resuscitation at 23 weeks (less 400g)
is appropriate
bull Difficulties in making accurate assessments before birth
bull Fetal weight can be inaccurate by 15-20
bull Small discrepancies in gestation of 1 or 2 weeks can have
major implications for outcome
bull Multiple gestation makes evaluation difficult
bull Counselling
bull But US legal trends restrict discretionary decision-making
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
The Marginally Viable Newborn Legal Challenges Conceptual Inadequacies and ReasonablenessSadath A Sayeed MD JD
The Journal of Law Medicine amp Ethics Volume 34 Issue 3 600-610 2006
Recommendations The Fetus and Newborn
Committee Canada
bull 22 weeks compassionate care only
bull 23-24 weeks careful consideration limited benefits and potential
harms of caesarean section and active resuscitation
bull Full care 25 weeks (survival rate is 50-80 with disability rates 10-25)
Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Brain development
bull 12-16 weeks neuronal proliferation
bull 12 - 20 weeks neuronal migration
bull 20 weeks neuronal organisation inside-out layering
of the cortical neurones synaptogenesis
bull 26 -28 weeks rapid gyral growth
bull Myelinization starts at 20 weeks gestation
continues for many years postnatally
bull 29-40 weeks 27 fold increase in brain volume
4 fold increase in grey matter volume
bull Brain folding coffee bean walnut
Gestational age are we always talking about
the same time
Pediatrics Vol 114 No 5 November 1 2004 pp 1362 -136 (4doi 101542peds2004-1915)
Estimate of gestational age
bull The best obstetric estimate is necessary
- gaps in obstetric information
- inherent variability (as great as 2 weeks) in traditional
methods of gestational age estimation
- postnatal physical examination inaccurate
bull First trimester ultrasound golden standard
(margin of error a few days)
bull Methods should be clearly stated
Wisserl J Et al Estimation of gestational age by transvaginal sonographic measurement of greatest embryonic length in
dated human embryos Ultrasound in Obstetrics amp Gynecology Volume 4 Issue 6 pages 457ndash462 1 November 1994
Bulletin of the World Health Organization The worldwide incidence of preterm birth a systematic review
of maternal mortality and morbidity Stacy Beck Daniel Wojdyla
Viability and its implications
bull Disability
bull Psychological bull emotional impact of raising a child with a disability
bull the child himself depression anxiety aggression lower self
concept (Rachel Levy Shifft and Gili Einat Journal of Clinical Child Psychology V 23 p 328-9)
bull Financial - US 2003
Premature newborns = US$181 billion in health care costs
= half of total hospital charges for newborn care
+ ongoing costs for the health system (14 billion on less of 125 USDday)
bull Societal
Thresholds of viability some numbers on
SURVIVALS
bull Dramatically improved during last 3 decades
bull Differences in methodology
bull Few studies have reported mortality and morbidity rates in gestational age-specific categories
Preterm Birth Causes Consequences and PreventionInstitute of Medicine (US) Committee on Understanding Premature
Birth and Assuring Healthy Outcomes Behrman RE Butler AS editorsWashington (DC) National Academies Press (US) 2007
Thresholds of viability some numbers on
SURVIVALS
ndash Risk of neonatal deaths not higher than 50 except for infants less
the 500g and 24 weeks gestation Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
ndash At 24 weeks survival = 58
ndash At 25 weeks = 77
ndash Not precised for lt 24 weeks
ndash Survival vary from 1 at 22 weeks to up to 44 at 25 weeks
ndash Before 21 weeks and six days no survival published
Brazier M et al Letting babies die J Med Ethics 2007 33 (3) 125-6
Thresholds of viability
bull Survival
ndash at 24 weeks 31
ndash at 25 weeks 50 Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
ndash at 23 and 24 weeks gestation varies from 10-50
ndash at 25 weeks gestation 50 - 80 Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
- 22w (0) 23w (29) 24w (50) 25w (65) Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely
preterm birth Keogh J et al Consensus Workshop Organising Committee
Thresholds of viability
bull gt 23 weeks gestation16 chance of surviving
bull At 24 weeks survival 44
bull At 25 weeks survival 63
bull Each day increases survival by 3
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity EPICure (UK Ireland)
bull Follow up of 78 of 308 children born lt 25 weeks + 6 days up to 6 years from 1995 on
bull 12 cerebral palsy bull lt 750g 30 - 50 moderate or severe disability
bull 41 cognitive problems (-2SD) compared to classmates
bull Survivers of 24 weeks 14 with no handicap
bull Survivers of 25 weeks 24 with no handicap
Marlow N Wolke D Bracewell MA Samara M The EPICure Study Group Neurologic disability at six years of age after
extremely preterm birth N Engl J Med 2005 352
EPICure
Morbidity EPIPAGE (France)
bull 77 of 2901 infants between 22 and 32 weeks
control group of term babies up to 5 years (not
finely sliced)
bull lt 27 weeks -1DS of QI attention deficit
language and behaviour disorders
Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
MorbidityThe American Academy of
Pediatrics
bull 30-50 of surviving children with lt750g or whose gestation lt25 weeks had moderate or severe disability
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
MorbidityNuffields (GB)
bull 23 - 24 weeks gestation 64 risk of serious disability
bull At 25 weeks risk of severe disability 40
bull Each day increases survival by 3
bull Girls have a weekrsquos advantage over preterm boys
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity Australia
bull Grey zone between 23-25 weeks + 6 days
bull Survival to discharge data
- 22w (0)
- 23w (29)
- 24w (50)
- 25w (65)
bull Proportion with no functional disability
23w (33) 24w (61) 25w (67)
Morbidity The Netherlands
Leiden follow up project data since 1983
Death or abnormal development
23-24 wks (92)
25 weeks (64)
26 weeks (35)
27-32 weeks (18)
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Rijken M et al Mortality and Neurologic Mental and Psychomotor Development at 2 Years in Infants Born less than 27 Weeks
Gestation The Leiden Follow-Up Project on Prematurity Pediatrics january 2003
Recommendations British Association of
Perinatal Medicine
22-28 weeks threshold of viability (under 26 weeks)
- Increasing risk with decreasing gestational age
serious ethical dilemmas
- Short notice decisions
- Need to balance maternal well-being against the
likely neonatal outcome
- Caesarean section in the babyrsquos interests
can rarely be justified prior to 25 weeks gestation
- Threshold viability infants should be followed up for
at least 2 years data collection
British Association of Perinatal Medicine Fetuses and newborn infants at the threshold of viability Pediatr 20021101024-27
Recommendations The American Academy
of Pediatrics bull 22-25 weeks gestation problematic
bull Non-initiation of resuscitation at 23 weeks (less 400g)
is appropriate
bull Difficulties in making accurate assessments before birth
bull Fetal weight can be inaccurate by 15-20
bull Small discrepancies in gestation of 1 or 2 weeks can have
major implications for outcome
bull Multiple gestation makes evaluation difficult
bull Counselling
bull But US legal trends restrict discretionary decision-making
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
The Marginally Viable Newborn Legal Challenges Conceptual Inadequacies and ReasonablenessSadath A Sayeed MD JD
The Journal of Law Medicine amp Ethics Volume 34 Issue 3 600-610 2006
Recommendations The Fetus and Newborn
Committee Canada
bull 22 weeks compassionate care only
bull 23-24 weeks careful consideration limited benefits and potential
harms of caesarean section and active resuscitation
bull Full care 25 weeks (survival rate is 50-80 with disability rates 10-25)
Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Gestational age are we always talking about
the same time
Pediatrics Vol 114 No 5 November 1 2004 pp 1362 -136 (4doi 101542peds2004-1915)
Estimate of gestational age
bull The best obstetric estimate is necessary
- gaps in obstetric information
- inherent variability (as great as 2 weeks) in traditional
methods of gestational age estimation
- postnatal physical examination inaccurate
bull First trimester ultrasound golden standard
(margin of error a few days)
bull Methods should be clearly stated
Wisserl J Et al Estimation of gestational age by transvaginal sonographic measurement of greatest embryonic length in
dated human embryos Ultrasound in Obstetrics amp Gynecology Volume 4 Issue 6 pages 457ndash462 1 November 1994
Bulletin of the World Health Organization The worldwide incidence of preterm birth a systematic review
of maternal mortality and morbidity Stacy Beck Daniel Wojdyla
Viability and its implications
bull Disability
bull Psychological bull emotional impact of raising a child with a disability
bull the child himself depression anxiety aggression lower self
concept (Rachel Levy Shifft and Gili Einat Journal of Clinical Child Psychology V 23 p 328-9)
bull Financial - US 2003
Premature newborns = US$181 billion in health care costs
= half of total hospital charges for newborn care
+ ongoing costs for the health system (14 billion on less of 125 USDday)
bull Societal
Thresholds of viability some numbers on
SURVIVALS
bull Dramatically improved during last 3 decades
bull Differences in methodology
bull Few studies have reported mortality and morbidity rates in gestational age-specific categories
Preterm Birth Causes Consequences and PreventionInstitute of Medicine (US) Committee on Understanding Premature
Birth and Assuring Healthy Outcomes Behrman RE Butler AS editorsWashington (DC) National Academies Press (US) 2007
Thresholds of viability some numbers on
SURVIVALS
ndash Risk of neonatal deaths not higher than 50 except for infants less
the 500g and 24 weeks gestation Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
ndash At 24 weeks survival = 58
ndash At 25 weeks = 77
ndash Not precised for lt 24 weeks
ndash Survival vary from 1 at 22 weeks to up to 44 at 25 weeks
ndash Before 21 weeks and six days no survival published
Brazier M et al Letting babies die J Med Ethics 2007 33 (3) 125-6
Thresholds of viability
bull Survival
ndash at 24 weeks 31
ndash at 25 weeks 50 Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
ndash at 23 and 24 weeks gestation varies from 10-50
ndash at 25 weeks gestation 50 - 80 Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
- 22w (0) 23w (29) 24w (50) 25w (65) Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely
preterm birth Keogh J et al Consensus Workshop Organising Committee
Thresholds of viability
bull gt 23 weeks gestation16 chance of surviving
bull At 24 weeks survival 44
bull At 25 weeks survival 63
bull Each day increases survival by 3
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity EPICure (UK Ireland)
bull Follow up of 78 of 308 children born lt 25 weeks + 6 days up to 6 years from 1995 on
bull 12 cerebral palsy bull lt 750g 30 - 50 moderate or severe disability
bull 41 cognitive problems (-2SD) compared to classmates
bull Survivers of 24 weeks 14 with no handicap
bull Survivers of 25 weeks 24 with no handicap
Marlow N Wolke D Bracewell MA Samara M The EPICure Study Group Neurologic disability at six years of age after
extremely preterm birth N Engl J Med 2005 352
EPICure
Morbidity EPIPAGE (France)
bull 77 of 2901 infants between 22 and 32 weeks
control group of term babies up to 5 years (not
finely sliced)
bull lt 27 weeks -1DS of QI attention deficit
language and behaviour disorders
Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
MorbidityThe American Academy of
Pediatrics
bull 30-50 of surviving children with lt750g or whose gestation lt25 weeks had moderate or severe disability
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
MorbidityNuffields (GB)
bull 23 - 24 weeks gestation 64 risk of serious disability
bull At 25 weeks risk of severe disability 40
bull Each day increases survival by 3
bull Girls have a weekrsquos advantage over preterm boys
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity Australia
bull Grey zone between 23-25 weeks + 6 days
bull Survival to discharge data
- 22w (0)
- 23w (29)
- 24w (50)
- 25w (65)
bull Proportion with no functional disability
23w (33) 24w (61) 25w (67)
Morbidity The Netherlands
Leiden follow up project data since 1983
Death or abnormal development
23-24 wks (92)
25 weeks (64)
26 weeks (35)
27-32 weeks (18)
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Rijken M et al Mortality and Neurologic Mental and Psychomotor Development at 2 Years in Infants Born less than 27 Weeks
Gestation The Leiden Follow-Up Project on Prematurity Pediatrics january 2003
Recommendations British Association of
Perinatal Medicine
22-28 weeks threshold of viability (under 26 weeks)
- Increasing risk with decreasing gestational age
serious ethical dilemmas
- Short notice decisions
- Need to balance maternal well-being against the
likely neonatal outcome
- Caesarean section in the babyrsquos interests
can rarely be justified prior to 25 weeks gestation
- Threshold viability infants should be followed up for
at least 2 years data collection
British Association of Perinatal Medicine Fetuses and newborn infants at the threshold of viability Pediatr 20021101024-27
Recommendations The American Academy
of Pediatrics bull 22-25 weeks gestation problematic
bull Non-initiation of resuscitation at 23 weeks (less 400g)
is appropriate
bull Difficulties in making accurate assessments before birth
bull Fetal weight can be inaccurate by 15-20
bull Small discrepancies in gestation of 1 or 2 weeks can have
major implications for outcome
bull Multiple gestation makes evaluation difficult
bull Counselling
bull But US legal trends restrict discretionary decision-making
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
The Marginally Viable Newborn Legal Challenges Conceptual Inadequacies and ReasonablenessSadath A Sayeed MD JD
The Journal of Law Medicine amp Ethics Volume 34 Issue 3 600-610 2006
Recommendations The Fetus and Newborn
Committee Canada
bull 22 weeks compassionate care only
bull 23-24 weeks careful consideration limited benefits and potential
harms of caesarean section and active resuscitation
bull Full care 25 weeks (survival rate is 50-80 with disability rates 10-25)
Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Estimate of gestational age
bull The best obstetric estimate is necessary
- gaps in obstetric information
- inherent variability (as great as 2 weeks) in traditional
methods of gestational age estimation
- postnatal physical examination inaccurate
bull First trimester ultrasound golden standard
(margin of error a few days)
bull Methods should be clearly stated
Wisserl J Et al Estimation of gestational age by transvaginal sonographic measurement of greatest embryonic length in
dated human embryos Ultrasound in Obstetrics amp Gynecology Volume 4 Issue 6 pages 457ndash462 1 November 1994
Bulletin of the World Health Organization The worldwide incidence of preterm birth a systematic review
of maternal mortality and morbidity Stacy Beck Daniel Wojdyla
Viability and its implications
bull Disability
bull Psychological bull emotional impact of raising a child with a disability
bull the child himself depression anxiety aggression lower self
concept (Rachel Levy Shifft and Gili Einat Journal of Clinical Child Psychology V 23 p 328-9)
bull Financial - US 2003
Premature newborns = US$181 billion in health care costs
= half of total hospital charges for newborn care
+ ongoing costs for the health system (14 billion on less of 125 USDday)
bull Societal
Thresholds of viability some numbers on
SURVIVALS
bull Dramatically improved during last 3 decades
bull Differences in methodology
bull Few studies have reported mortality and morbidity rates in gestational age-specific categories
Preterm Birth Causes Consequences and PreventionInstitute of Medicine (US) Committee on Understanding Premature
Birth and Assuring Healthy Outcomes Behrman RE Butler AS editorsWashington (DC) National Academies Press (US) 2007
Thresholds of viability some numbers on
SURVIVALS
ndash Risk of neonatal deaths not higher than 50 except for infants less
the 500g and 24 weeks gestation Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
ndash At 24 weeks survival = 58
ndash At 25 weeks = 77
ndash Not precised for lt 24 weeks
ndash Survival vary from 1 at 22 weeks to up to 44 at 25 weeks
ndash Before 21 weeks and six days no survival published
Brazier M et al Letting babies die J Med Ethics 2007 33 (3) 125-6
Thresholds of viability
bull Survival
ndash at 24 weeks 31
ndash at 25 weeks 50 Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
ndash at 23 and 24 weeks gestation varies from 10-50
ndash at 25 weeks gestation 50 - 80 Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
- 22w (0) 23w (29) 24w (50) 25w (65) Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely
preterm birth Keogh J et al Consensus Workshop Organising Committee
Thresholds of viability
bull gt 23 weeks gestation16 chance of surviving
bull At 24 weeks survival 44
bull At 25 weeks survival 63
bull Each day increases survival by 3
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity EPICure (UK Ireland)
bull Follow up of 78 of 308 children born lt 25 weeks + 6 days up to 6 years from 1995 on
bull 12 cerebral palsy bull lt 750g 30 - 50 moderate or severe disability
bull 41 cognitive problems (-2SD) compared to classmates
bull Survivers of 24 weeks 14 with no handicap
bull Survivers of 25 weeks 24 with no handicap
Marlow N Wolke D Bracewell MA Samara M The EPICure Study Group Neurologic disability at six years of age after
extremely preterm birth N Engl J Med 2005 352
EPICure
Morbidity EPIPAGE (France)
bull 77 of 2901 infants between 22 and 32 weeks
control group of term babies up to 5 years (not
finely sliced)
bull lt 27 weeks -1DS of QI attention deficit
language and behaviour disorders
Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
MorbidityThe American Academy of
Pediatrics
bull 30-50 of surviving children with lt750g or whose gestation lt25 weeks had moderate or severe disability
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
MorbidityNuffields (GB)
bull 23 - 24 weeks gestation 64 risk of serious disability
bull At 25 weeks risk of severe disability 40
bull Each day increases survival by 3
bull Girls have a weekrsquos advantage over preterm boys
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity Australia
bull Grey zone between 23-25 weeks + 6 days
bull Survival to discharge data
- 22w (0)
- 23w (29)
- 24w (50)
- 25w (65)
bull Proportion with no functional disability
23w (33) 24w (61) 25w (67)
Morbidity The Netherlands
Leiden follow up project data since 1983
Death or abnormal development
23-24 wks (92)
25 weeks (64)
26 weeks (35)
27-32 weeks (18)
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Rijken M et al Mortality and Neurologic Mental and Psychomotor Development at 2 Years in Infants Born less than 27 Weeks
Gestation The Leiden Follow-Up Project on Prematurity Pediatrics january 2003
Recommendations British Association of
Perinatal Medicine
22-28 weeks threshold of viability (under 26 weeks)
- Increasing risk with decreasing gestational age
serious ethical dilemmas
- Short notice decisions
- Need to balance maternal well-being against the
likely neonatal outcome
- Caesarean section in the babyrsquos interests
can rarely be justified prior to 25 weeks gestation
- Threshold viability infants should be followed up for
at least 2 years data collection
British Association of Perinatal Medicine Fetuses and newborn infants at the threshold of viability Pediatr 20021101024-27
Recommendations The American Academy
of Pediatrics bull 22-25 weeks gestation problematic
bull Non-initiation of resuscitation at 23 weeks (less 400g)
is appropriate
bull Difficulties in making accurate assessments before birth
bull Fetal weight can be inaccurate by 15-20
bull Small discrepancies in gestation of 1 or 2 weeks can have
major implications for outcome
bull Multiple gestation makes evaluation difficult
bull Counselling
bull But US legal trends restrict discretionary decision-making
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
The Marginally Viable Newborn Legal Challenges Conceptual Inadequacies and ReasonablenessSadath A Sayeed MD JD
The Journal of Law Medicine amp Ethics Volume 34 Issue 3 600-610 2006
Recommendations The Fetus and Newborn
Committee Canada
bull 22 weeks compassionate care only
bull 23-24 weeks careful consideration limited benefits and potential
harms of caesarean section and active resuscitation
bull Full care 25 weeks (survival rate is 50-80 with disability rates 10-25)
Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Viability and its implications
bull Disability
bull Psychological bull emotional impact of raising a child with a disability
bull the child himself depression anxiety aggression lower self
concept (Rachel Levy Shifft and Gili Einat Journal of Clinical Child Psychology V 23 p 328-9)
bull Financial - US 2003
Premature newborns = US$181 billion in health care costs
= half of total hospital charges for newborn care
+ ongoing costs for the health system (14 billion on less of 125 USDday)
bull Societal
Thresholds of viability some numbers on
SURVIVALS
bull Dramatically improved during last 3 decades
bull Differences in methodology
bull Few studies have reported mortality and morbidity rates in gestational age-specific categories
Preterm Birth Causes Consequences and PreventionInstitute of Medicine (US) Committee on Understanding Premature
Birth and Assuring Healthy Outcomes Behrman RE Butler AS editorsWashington (DC) National Academies Press (US) 2007
Thresholds of viability some numbers on
SURVIVALS
ndash Risk of neonatal deaths not higher than 50 except for infants less
the 500g and 24 weeks gestation Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
ndash At 24 weeks survival = 58
ndash At 25 weeks = 77
ndash Not precised for lt 24 weeks
ndash Survival vary from 1 at 22 weeks to up to 44 at 25 weeks
ndash Before 21 weeks and six days no survival published
Brazier M et al Letting babies die J Med Ethics 2007 33 (3) 125-6
Thresholds of viability
bull Survival
ndash at 24 weeks 31
ndash at 25 weeks 50 Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
ndash at 23 and 24 weeks gestation varies from 10-50
ndash at 25 weeks gestation 50 - 80 Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
- 22w (0) 23w (29) 24w (50) 25w (65) Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely
preterm birth Keogh J et al Consensus Workshop Organising Committee
Thresholds of viability
bull gt 23 weeks gestation16 chance of surviving
bull At 24 weeks survival 44
bull At 25 weeks survival 63
bull Each day increases survival by 3
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity EPICure (UK Ireland)
bull Follow up of 78 of 308 children born lt 25 weeks + 6 days up to 6 years from 1995 on
bull 12 cerebral palsy bull lt 750g 30 - 50 moderate or severe disability
bull 41 cognitive problems (-2SD) compared to classmates
bull Survivers of 24 weeks 14 with no handicap
bull Survivers of 25 weeks 24 with no handicap
Marlow N Wolke D Bracewell MA Samara M The EPICure Study Group Neurologic disability at six years of age after
extremely preterm birth N Engl J Med 2005 352
EPICure
Morbidity EPIPAGE (France)
bull 77 of 2901 infants between 22 and 32 weeks
control group of term babies up to 5 years (not
finely sliced)
bull lt 27 weeks -1DS of QI attention deficit
language and behaviour disorders
Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
MorbidityThe American Academy of
Pediatrics
bull 30-50 of surviving children with lt750g or whose gestation lt25 weeks had moderate or severe disability
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
MorbidityNuffields (GB)
bull 23 - 24 weeks gestation 64 risk of serious disability
bull At 25 weeks risk of severe disability 40
bull Each day increases survival by 3
bull Girls have a weekrsquos advantage over preterm boys
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity Australia
bull Grey zone between 23-25 weeks + 6 days
bull Survival to discharge data
- 22w (0)
- 23w (29)
- 24w (50)
- 25w (65)
bull Proportion with no functional disability
23w (33) 24w (61) 25w (67)
Morbidity The Netherlands
Leiden follow up project data since 1983
Death or abnormal development
23-24 wks (92)
25 weeks (64)
26 weeks (35)
27-32 weeks (18)
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Rijken M et al Mortality and Neurologic Mental and Psychomotor Development at 2 Years in Infants Born less than 27 Weeks
Gestation The Leiden Follow-Up Project on Prematurity Pediatrics january 2003
Recommendations British Association of
Perinatal Medicine
22-28 weeks threshold of viability (under 26 weeks)
- Increasing risk with decreasing gestational age
serious ethical dilemmas
- Short notice decisions
- Need to balance maternal well-being against the
likely neonatal outcome
- Caesarean section in the babyrsquos interests
can rarely be justified prior to 25 weeks gestation
- Threshold viability infants should be followed up for
at least 2 years data collection
British Association of Perinatal Medicine Fetuses and newborn infants at the threshold of viability Pediatr 20021101024-27
Recommendations The American Academy
of Pediatrics bull 22-25 weeks gestation problematic
bull Non-initiation of resuscitation at 23 weeks (less 400g)
is appropriate
bull Difficulties in making accurate assessments before birth
bull Fetal weight can be inaccurate by 15-20
bull Small discrepancies in gestation of 1 or 2 weeks can have
major implications for outcome
bull Multiple gestation makes evaluation difficult
bull Counselling
bull But US legal trends restrict discretionary decision-making
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
The Marginally Viable Newborn Legal Challenges Conceptual Inadequacies and ReasonablenessSadath A Sayeed MD JD
The Journal of Law Medicine amp Ethics Volume 34 Issue 3 600-610 2006
Recommendations The Fetus and Newborn
Committee Canada
bull 22 weeks compassionate care only
bull 23-24 weeks careful consideration limited benefits and potential
harms of caesarean section and active resuscitation
bull Full care 25 weeks (survival rate is 50-80 with disability rates 10-25)
Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Thresholds of viability some numbers on
SURVIVALS
bull Dramatically improved during last 3 decades
bull Differences in methodology
bull Few studies have reported mortality and morbidity rates in gestational age-specific categories
Preterm Birth Causes Consequences and PreventionInstitute of Medicine (US) Committee on Understanding Premature
Birth and Assuring Healthy Outcomes Behrman RE Butler AS editorsWashington (DC) National Academies Press (US) 2007
Thresholds of viability some numbers on
SURVIVALS
ndash Risk of neonatal deaths not higher than 50 except for infants less
the 500g and 24 weeks gestation Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
ndash At 24 weeks survival = 58
ndash At 25 weeks = 77
ndash Not precised for lt 24 weeks
ndash Survival vary from 1 at 22 weeks to up to 44 at 25 weeks
ndash Before 21 weeks and six days no survival published
Brazier M et al Letting babies die J Med Ethics 2007 33 (3) 125-6
Thresholds of viability
bull Survival
ndash at 24 weeks 31
ndash at 25 weeks 50 Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
ndash at 23 and 24 weeks gestation varies from 10-50
ndash at 25 weeks gestation 50 - 80 Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
- 22w (0) 23w (29) 24w (50) 25w (65) Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely
preterm birth Keogh J et al Consensus Workshop Organising Committee
Thresholds of viability
bull gt 23 weeks gestation16 chance of surviving
bull At 24 weeks survival 44
bull At 25 weeks survival 63
bull Each day increases survival by 3
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity EPICure (UK Ireland)
bull Follow up of 78 of 308 children born lt 25 weeks + 6 days up to 6 years from 1995 on
bull 12 cerebral palsy bull lt 750g 30 - 50 moderate or severe disability
bull 41 cognitive problems (-2SD) compared to classmates
bull Survivers of 24 weeks 14 with no handicap
bull Survivers of 25 weeks 24 with no handicap
Marlow N Wolke D Bracewell MA Samara M The EPICure Study Group Neurologic disability at six years of age after
extremely preterm birth N Engl J Med 2005 352
EPICure
Morbidity EPIPAGE (France)
bull 77 of 2901 infants between 22 and 32 weeks
control group of term babies up to 5 years (not
finely sliced)
bull lt 27 weeks -1DS of QI attention deficit
language and behaviour disorders
Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
MorbidityThe American Academy of
Pediatrics
bull 30-50 of surviving children with lt750g or whose gestation lt25 weeks had moderate or severe disability
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
MorbidityNuffields (GB)
bull 23 - 24 weeks gestation 64 risk of serious disability
bull At 25 weeks risk of severe disability 40
bull Each day increases survival by 3
bull Girls have a weekrsquos advantage over preterm boys
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity Australia
bull Grey zone between 23-25 weeks + 6 days
bull Survival to discharge data
- 22w (0)
- 23w (29)
- 24w (50)
- 25w (65)
bull Proportion with no functional disability
23w (33) 24w (61) 25w (67)
Morbidity The Netherlands
Leiden follow up project data since 1983
Death or abnormal development
23-24 wks (92)
25 weeks (64)
26 weeks (35)
27-32 weeks (18)
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Rijken M et al Mortality and Neurologic Mental and Psychomotor Development at 2 Years in Infants Born less than 27 Weeks
Gestation The Leiden Follow-Up Project on Prematurity Pediatrics january 2003
Recommendations British Association of
Perinatal Medicine
22-28 weeks threshold of viability (under 26 weeks)
- Increasing risk with decreasing gestational age
serious ethical dilemmas
- Short notice decisions
- Need to balance maternal well-being against the
likely neonatal outcome
- Caesarean section in the babyrsquos interests
can rarely be justified prior to 25 weeks gestation
- Threshold viability infants should be followed up for
at least 2 years data collection
British Association of Perinatal Medicine Fetuses and newborn infants at the threshold of viability Pediatr 20021101024-27
Recommendations The American Academy
of Pediatrics bull 22-25 weeks gestation problematic
bull Non-initiation of resuscitation at 23 weeks (less 400g)
is appropriate
bull Difficulties in making accurate assessments before birth
bull Fetal weight can be inaccurate by 15-20
bull Small discrepancies in gestation of 1 or 2 weeks can have
major implications for outcome
bull Multiple gestation makes evaluation difficult
bull Counselling
bull But US legal trends restrict discretionary decision-making
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
The Marginally Viable Newborn Legal Challenges Conceptual Inadequacies and ReasonablenessSadath A Sayeed MD JD
The Journal of Law Medicine amp Ethics Volume 34 Issue 3 600-610 2006
Recommendations The Fetus and Newborn
Committee Canada
bull 22 weeks compassionate care only
bull 23-24 weeks careful consideration limited benefits and potential
harms of caesarean section and active resuscitation
bull Full care 25 weeks (survival rate is 50-80 with disability rates 10-25)
Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Thresholds of viability some numbers on
SURVIVALS
ndash Risk of neonatal deaths not higher than 50 except for infants less
the 500g and 24 weeks gestation Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
ndash At 24 weeks survival = 58
ndash At 25 weeks = 77
ndash Not precised for lt 24 weeks
ndash Survival vary from 1 at 22 weeks to up to 44 at 25 weeks
ndash Before 21 weeks and six days no survival published
Brazier M et al Letting babies die J Med Ethics 2007 33 (3) 125-6
Thresholds of viability
bull Survival
ndash at 24 weeks 31
ndash at 25 weeks 50 Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
ndash at 23 and 24 weeks gestation varies from 10-50
ndash at 25 weeks gestation 50 - 80 Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
- 22w (0) 23w (29) 24w (50) 25w (65) Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely
preterm birth Keogh J et al Consensus Workshop Organising Committee
Thresholds of viability
bull gt 23 weeks gestation16 chance of surviving
bull At 24 weeks survival 44
bull At 25 weeks survival 63
bull Each day increases survival by 3
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity EPICure (UK Ireland)
bull Follow up of 78 of 308 children born lt 25 weeks + 6 days up to 6 years from 1995 on
bull 12 cerebral palsy bull lt 750g 30 - 50 moderate or severe disability
bull 41 cognitive problems (-2SD) compared to classmates
bull Survivers of 24 weeks 14 with no handicap
bull Survivers of 25 weeks 24 with no handicap
Marlow N Wolke D Bracewell MA Samara M The EPICure Study Group Neurologic disability at six years of age after
extremely preterm birth N Engl J Med 2005 352
EPICure
Morbidity EPIPAGE (France)
bull 77 of 2901 infants between 22 and 32 weeks
control group of term babies up to 5 years (not
finely sliced)
bull lt 27 weeks -1DS of QI attention deficit
language and behaviour disorders
Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
MorbidityThe American Academy of
Pediatrics
bull 30-50 of surviving children with lt750g or whose gestation lt25 weeks had moderate or severe disability
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
MorbidityNuffields (GB)
bull 23 - 24 weeks gestation 64 risk of serious disability
bull At 25 weeks risk of severe disability 40
bull Each day increases survival by 3
bull Girls have a weekrsquos advantage over preterm boys
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity Australia
bull Grey zone between 23-25 weeks + 6 days
bull Survival to discharge data
- 22w (0)
- 23w (29)
- 24w (50)
- 25w (65)
bull Proportion with no functional disability
23w (33) 24w (61) 25w (67)
Morbidity The Netherlands
Leiden follow up project data since 1983
Death or abnormal development
23-24 wks (92)
25 weeks (64)
26 weeks (35)
27-32 weeks (18)
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Rijken M et al Mortality and Neurologic Mental and Psychomotor Development at 2 Years in Infants Born less than 27 Weeks
Gestation The Leiden Follow-Up Project on Prematurity Pediatrics january 2003
Recommendations British Association of
Perinatal Medicine
22-28 weeks threshold of viability (under 26 weeks)
- Increasing risk with decreasing gestational age
serious ethical dilemmas
- Short notice decisions
- Need to balance maternal well-being against the
likely neonatal outcome
- Caesarean section in the babyrsquos interests
can rarely be justified prior to 25 weeks gestation
- Threshold viability infants should be followed up for
at least 2 years data collection
British Association of Perinatal Medicine Fetuses and newborn infants at the threshold of viability Pediatr 20021101024-27
Recommendations The American Academy
of Pediatrics bull 22-25 weeks gestation problematic
bull Non-initiation of resuscitation at 23 weeks (less 400g)
is appropriate
bull Difficulties in making accurate assessments before birth
bull Fetal weight can be inaccurate by 15-20
bull Small discrepancies in gestation of 1 or 2 weeks can have
major implications for outcome
bull Multiple gestation makes evaluation difficult
bull Counselling
bull But US legal trends restrict discretionary decision-making
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
The Marginally Viable Newborn Legal Challenges Conceptual Inadequacies and ReasonablenessSadath A Sayeed MD JD
The Journal of Law Medicine amp Ethics Volume 34 Issue 3 600-610 2006
Recommendations The Fetus and Newborn
Committee Canada
bull 22 weeks compassionate care only
bull 23-24 weeks careful consideration limited benefits and potential
harms of caesarean section and active resuscitation
bull Full care 25 weeks (survival rate is 50-80 with disability rates 10-25)
Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Thresholds of viability
bull Survival
ndash at 24 weeks 31
ndash at 25 weeks 50 Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
ndash at 23 and 24 weeks gestation varies from 10-50
ndash at 25 weeks gestation 50 - 80 Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
- 22w (0) 23w (29) 24w (50) 25w (65) Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely
preterm birth Keogh J et al Consensus Workshop Organising Committee
Thresholds of viability
bull gt 23 weeks gestation16 chance of surviving
bull At 24 weeks survival 44
bull At 25 weeks survival 63
bull Each day increases survival by 3
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity EPICure (UK Ireland)
bull Follow up of 78 of 308 children born lt 25 weeks + 6 days up to 6 years from 1995 on
bull 12 cerebral palsy bull lt 750g 30 - 50 moderate or severe disability
bull 41 cognitive problems (-2SD) compared to classmates
bull Survivers of 24 weeks 14 with no handicap
bull Survivers of 25 weeks 24 with no handicap
Marlow N Wolke D Bracewell MA Samara M The EPICure Study Group Neurologic disability at six years of age after
extremely preterm birth N Engl J Med 2005 352
EPICure
Morbidity EPIPAGE (France)
bull 77 of 2901 infants between 22 and 32 weeks
control group of term babies up to 5 years (not
finely sliced)
bull lt 27 weeks -1DS of QI attention deficit
language and behaviour disorders
Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
MorbidityThe American Academy of
Pediatrics
bull 30-50 of surviving children with lt750g or whose gestation lt25 weeks had moderate or severe disability
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
MorbidityNuffields (GB)
bull 23 - 24 weeks gestation 64 risk of serious disability
bull At 25 weeks risk of severe disability 40
bull Each day increases survival by 3
bull Girls have a weekrsquos advantage over preterm boys
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity Australia
bull Grey zone between 23-25 weeks + 6 days
bull Survival to discharge data
- 22w (0)
- 23w (29)
- 24w (50)
- 25w (65)
bull Proportion with no functional disability
23w (33) 24w (61) 25w (67)
Morbidity The Netherlands
Leiden follow up project data since 1983
Death or abnormal development
23-24 wks (92)
25 weeks (64)
26 weeks (35)
27-32 weeks (18)
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Rijken M et al Mortality and Neurologic Mental and Psychomotor Development at 2 Years in Infants Born less than 27 Weeks
Gestation The Leiden Follow-Up Project on Prematurity Pediatrics january 2003
Recommendations British Association of
Perinatal Medicine
22-28 weeks threshold of viability (under 26 weeks)
- Increasing risk with decreasing gestational age
serious ethical dilemmas
- Short notice decisions
- Need to balance maternal well-being against the
likely neonatal outcome
- Caesarean section in the babyrsquos interests
can rarely be justified prior to 25 weeks gestation
- Threshold viability infants should be followed up for
at least 2 years data collection
British Association of Perinatal Medicine Fetuses and newborn infants at the threshold of viability Pediatr 20021101024-27
Recommendations The American Academy
of Pediatrics bull 22-25 weeks gestation problematic
bull Non-initiation of resuscitation at 23 weeks (less 400g)
is appropriate
bull Difficulties in making accurate assessments before birth
bull Fetal weight can be inaccurate by 15-20
bull Small discrepancies in gestation of 1 or 2 weeks can have
major implications for outcome
bull Multiple gestation makes evaluation difficult
bull Counselling
bull But US legal trends restrict discretionary decision-making
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
The Marginally Viable Newborn Legal Challenges Conceptual Inadequacies and ReasonablenessSadath A Sayeed MD JD
The Journal of Law Medicine amp Ethics Volume 34 Issue 3 600-610 2006
Recommendations The Fetus and Newborn
Committee Canada
bull 22 weeks compassionate care only
bull 23-24 weeks careful consideration limited benefits and potential
harms of caesarean section and active resuscitation
bull Full care 25 weeks (survival rate is 50-80 with disability rates 10-25)
Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Thresholds of viability
bull gt 23 weeks gestation16 chance of surviving
bull At 24 weeks survival 44
bull At 25 weeks survival 63
bull Each day increases survival by 3
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity EPICure (UK Ireland)
bull Follow up of 78 of 308 children born lt 25 weeks + 6 days up to 6 years from 1995 on
bull 12 cerebral palsy bull lt 750g 30 - 50 moderate or severe disability
bull 41 cognitive problems (-2SD) compared to classmates
bull Survivers of 24 weeks 14 with no handicap
bull Survivers of 25 weeks 24 with no handicap
Marlow N Wolke D Bracewell MA Samara M The EPICure Study Group Neurologic disability at six years of age after
extremely preterm birth N Engl J Med 2005 352
EPICure
Morbidity EPIPAGE (France)
bull 77 of 2901 infants between 22 and 32 weeks
control group of term babies up to 5 years (not
finely sliced)
bull lt 27 weeks -1DS of QI attention deficit
language and behaviour disorders
Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
MorbidityThe American Academy of
Pediatrics
bull 30-50 of surviving children with lt750g or whose gestation lt25 weeks had moderate or severe disability
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
MorbidityNuffields (GB)
bull 23 - 24 weeks gestation 64 risk of serious disability
bull At 25 weeks risk of severe disability 40
bull Each day increases survival by 3
bull Girls have a weekrsquos advantage over preterm boys
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity Australia
bull Grey zone between 23-25 weeks + 6 days
bull Survival to discharge data
- 22w (0)
- 23w (29)
- 24w (50)
- 25w (65)
bull Proportion with no functional disability
23w (33) 24w (61) 25w (67)
Morbidity The Netherlands
Leiden follow up project data since 1983
Death or abnormal development
23-24 wks (92)
25 weeks (64)
26 weeks (35)
27-32 weeks (18)
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Rijken M et al Mortality and Neurologic Mental and Psychomotor Development at 2 Years in Infants Born less than 27 Weeks
Gestation The Leiden Follow-Up Project on Prematurity Pediatrics january 2003
Recommendations British Association of
Perinatal Medicine
22-28 weeks threshold of viability (under 26 weeks)
- Increasing risk with decreasing gestational age
serious ethical dilemmas
- Short notice decisions
- Need to balance maternal well-being against the
likely neonatal outcome
- Caesarean section in the babyrsquos interests
can rarely be justified prior to 25 weeks gestation
- Threshold viability infants should be followed up for
at least 2 years data collection
British Association of Perinatal Medicine Fetuses and newborn infants at the threshold of viability Pediatr 20021101024-27
Recommendations The American Academy
of Pediatrics bull 22-25 weeks gestation problematic
bull Non-initiation of resuscitation at 23 weeks (less 400g)
is appropriate
bull Difficulties in making accurate assessments before birth
bull Fetal weight can be inaccurate by 15-20
bull Small discrepancies in gestation of 1 or 2 weeks can have
major implications for outcome
bull Multiple gestation makes evaluation difficult
bull Counselling
bull But US legal trends restrict discretionary decision-making
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
The Marginally Viable Newborn Legal Challenges Conceptual Inadequacies and ReasonablenessSadath A Sayeed MD JD
The Journal of Law Medicine amp Ethics Volume 34 Issue 3 600-610 2006
Recommendations The Fetus and Newborn
Committee Canada
bull 22 weeks compassionate care only
bull 23-24 weeks careful consideration limited benefits and potential
harms of caesarean section and active resuscitation
bull Full care 25 weeks (survival rate is 50-80 with disability rates 10-25)
Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Morbidity EPICure (UK Ireland)
bull Follow up of 78 of 308 children born lt 25 weeks + 6 days up to 6 years from 1995 on
bull 12 cerebral palsy bull lt 750g 30 - 50 moderate or severe disability
bull 41 cognitive problems (-2SD) compared to classmates
bull Survivers of 24 weeks 14 with no handicap
bull Survivers of 25 weeks 24 with no handicap
Marlow N Wolke D Bracewell MA Samara M The EPICure Study Group Neurologic disability at six years of age after
extremely preterm birth N Engl J Med 2005 352
EPICure
Morbidity EPIPAGE (France)
bull 77 of 2901 infants between 22 and 32 weeks
control group of term babies up to 5 years (not
finely sliced)
bull lt 27 weeks -1DS of QI attention deficit
language and behaviour disorders
Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
MorbidityThe American Academy of
Pediatrics
bull 30-50 of surviving children with lt750g or whose gestation lt25 weeks had moderate or severe disability
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
MorbidityNuffields (GB)
bull 23 - 24 weeks gestation 64 risk of serious disability
bull At 25 weeks risk of severe disability 40
bull Each day increases survival by 3
bull Girls have a weekrsquos advantage over preterm boys
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity Australia
bull Grey zone between 23-25 weeks + 6 days
bull Survival to discharge data
- 22w (0)
- 23w (29)
- 24w (50)
- 25w (65)
bull Proportion with no functional disability
23w (33) 24w (61) 25w (67)
Morbidity The Netherlands
Leiden follow up project data since 1983
Death or abnormal development
23-24 wks (92)
25 weeks (64)
26 weeks (35)
27-32 weeks (18)
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Rijken M et al Mortality and Neurologic Mental and Psychomotor Development at 2 Years in Infants Born less than 27 Weeks
Gestation The Leiden Follow-Up Project on Prematurity Pediatrics january 2003
Recommendations British Association of
Perinatal Medicine
22-28 weeks threshold of viability (under 26 weeks)
- Increasing risk with decreasing gestational age
serious ethical dilemmas
- Short notice decisions
- Need to balance maternal well-being against the
likely neonatal outcome
- Caesarean section in the babyrsquos interests
can rarely be justified prior to 25 weeks gestation
- Threshold viability infants should be followed up for
at least 2 years data collection
British Association of Perinatal Medicine Fetuses and newborn infants at the threshold of viability Pediatr 20021101024-27
Recommendations The American Academy
of Pediatrics bull 22-25 weeks gestation problematic
bull Non-initiation of resuscitation at 23 weeks (less 400g)
is appropriate
bull Difficulties in making accurate assessments before birth
bull Fetal weight can be inaccurate by 15-20
bull Small discrepancies in gestation of 1 or 2 weeks can have
major implications for outcome
bull Multiple gestation makes evaluation difficult
bull Counselling
bull But US legal trends restrict discretionary decision-making
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
The Marginally Viable Newborn Legal Challenges Conceptual Inadequacies and ReasonablenessSadath A Sayeed MD JD
The Journal of Law Medicine amp Ethics Volume 34 Issue 3 600-610 2006
Recommendations The Fetus and Newborn
Committee Canada
bull 22 weeks compassionate care only
bull 23-24 weeks careful consideration limited benefits and potential
harms of caesarean section and active resuscitation
bull Full care 25 weeks (survival rate is 50-80 with disability rates 10-25)
Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
EPICure
Morbidity EPIPAGE (France)
bull 77 of 2901 infants between 22 and 32 weeks
control group of term babies up to 5 years (not
finely sliced)
bull lt 27 weeks -1DS of QI attention deficit
language and behaviour disorders
Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
MorbidityThe American Academy of
Pediatrics
bull 30-50 of surviving children with lt750g or whose gestation lt25 weeks had moderate or severe disability
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
MorbidityNuffields (GB)
bull 23 - 24 weeks gestation 64 risk of serious disability
bull At 25 weeks risk of severe disability 40
bull Each day increases survival by 3
bull Girls have a weekrsquos advantage over preterm boys
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity Australia
bull Grey zone between 23-25 weeks + 6 days
bull Survival to discharge data
- 22w (0)
- 23w (29)
- 24w (50)
- 25w (65)
bull Proportion with no functional disability
23w (33) 24w (61) 25w (67)
Morbidity The Netherlands
Leiden follow up project data since 1983
Death or abnormal development
23-24 wks (92)
25 weeks (64)
26 weeks (35)
27-32 weeks (18)
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Rijken M et al Mortality and Neurologic Mental and Psychomotor Development at 2 Years in Infants Born less than 27 Weeks
Gestation The Leiden Follow-Up Project on Prematurity Pediatrics january 2003
Recommendations British Association of
Perinatal Medicine
22-28 weeks threshold of viability (under 26 weeks)
- Increasing risk with decreasing gestational age
serious ethical dilemmas
- Short notice decisions
- Need to balance maternal well-being against the
likely neonatal outcome
- Caesarean section in the babyrsquos interests
can rarely be justified prior to 25 weeks gestation
- Threshold viability infants should be followed up for
at least 2 years data collection
British Association of Perinatal Medicine Fetuses and newborn infants at the threshold of viability Pediatr 20021101024-27
Recommendations The American Academy
of Pediatrics bull 22-25 weeks gestation problematic
bull Non-initiation of resuscitation at 23 weeks (less 400g)
is appropriate
bull Difficulties in making accurate assessments before birth
bull Fetal weight can be inaccurate by 15-20
bull Small discrepancies in gestation of 1 or 2 weeks can have
major implications for outcome
bull Multiple gestation makes evaluation difficult
bull Counselling
bull But US legal trends restrict discretionary decision-making
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
The Marginally Viable Newborn Legal Challenges Conceptual Inadequacies and ReasonablenessSadath A Sayeed MD JD
The Journal of Law Medicine amp Ethics Volume 34 Issue 3 600-610 2006
Recommendations The Fetus and Newborn
Committee Canada
bull 22 weeks compassionate care only
bull 23-24 weeks careful consideration limited benefits and potential
harms of caesarean section and active resuscitation
bull Full care 25 weeks (survival rate is 50-80 with disability rates 10-25)
Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Morbidity EPIPAGE (France)
bull 77 of 2901 infants between 22 and 32 weeks
control group of term babies up to 5 years (not
finely sliced)
bull lt 27 weeks -1DS of QI attention deficit
language and behaviour disorders
Larroque B Ancel PY Marchand-Martin L Cambonie G Fresson J Pierrat V et al Special care school diffiulties in
8- year-old very preterm children the Epipage cohort study PLoS ONE 2011 6 e21361
MorbidityThe American Academy of
Pediatrics
bull 30-50 of surviving children with lt750g or whose gestation lt25 weeks had moderate or severe disability
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
MorbidityNuffields (GB)
bull 23 - 24 weeks gestation 64 risk of serious disability
bull At 25 weeks risk of severe disability 40
bull Each day increases survival by 3
bull Girls have a weekrsquos advantage over preterm boys
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity Australia
bull Grey zone between 23-25 weeks + 6 days
bull Survival to discharge data
- 22w (0)
- 23w (29)
- 24w (50)
- 25w (65)
bull Proportion with no functional disability
23w (33) 24w (61) 25w (67)
Morbidity The Netherlands
Leiden follow up project data since 1983
Death or abnormal development
23-24 wks (92)
25 weeks (64)
26 weeks (35)
27-32 weeks (18)
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Rijken M et al Mortality and Neurologic Mental and Psychomotor Development at 2 Years in Infants Born less than 27 Weeks
Gestation The Leiden Follow-Up Project on Prematurity Pediatrics january 2003
Recommendations British Association of
Perinatal Medicine
22-28 weeks threshold of viability (under 26 weeks)
- Increasing risk with decreasing gestational age
serious ethical dilemmas
- Short notice decisions
- Need to balance maternal well-being against the
likely neonatal outcome
- Caesarean section in the babyrsquos interests
can rarely be justified prior to 25 weeks gestation
- Threshold viability infants should be followed up for
at least 2 years data collection
British Association of Perinatal Medicine Fetuses and newborn infants at the threshold of viability Pediatr 20021101024-27
Recommendations The American Academy
of Pediatrics bull 22-25 weeks gestation problematic
bull Non-initiation of resuscitation at 23 weeks (less 400g)
is appropriate
bull Difficulties in making accurate assessments before birth
bull Fetal weight can be inaccurate by 15-20
bull Small discrepancies in gestation of 1 or 2 weeks can have
major implications for outcome
bull Multiple gestation makes evaluation difficult
bull Counselling
bull But US legal trends restrict discretionary decision-making
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
The Marginally Viable Newborn Legal Challenges Conceptual Inadequacies and ReasonablenessSadath A Sayeed MD JD
The Journal of Law Medicine amp Ethics Volume 34 Issue 3 600-610 2006
Recommendations The Fetus and Newborn
Committee Canada
bull 22 weeks compassionate care only
bull 23-24 weeks careful consideration limited benefits and potential
harms of caesarean section and active resuscitation
bull Full care 25 weeks (survival rate is 50-80 with disability rates 10-25)
Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
MorbidityThe American Academy of
Pediatrics
bull 30-50 of surviving children with lt750g or whose gestation lt25 weeks had moderate or severe disability
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
MorbidityNuffields (GB)
bull 23 - 24 weeks gestation 64 risk of serious disability
bull At 25 weeks risk of severe disability 40
bull Each day increases survival by 3
bull Girls have a weekrsquos advantage over preterm boys
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity Australia
bull Grey zone between 23-25 weeks + 6 days
bull Survival to discharge data
- 22w (0)
- 23w (29)
- 24w (50)
- 25w (65)
bull Proportion with no functional disability
23w (33) 24w (61) 25w (67)
Morbidity The Netherlands
Leiden follow up project data since 1983
Death or abnormal development
23-24 wks (92)
25 weeks (64)
26 weeks (35)
27-32 weeks (18)
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Rijken M et al Mortality and Neurologic Mental and Psychomotor Development at 2 Years in Infants Born less than 27 Weeks
Gestation The Leiden Follow-Up Project on Prematurity Pediatrics january 2003
Recommendations British Association of
Perinatal Medicine
22-28 weeks threshold of viability (under 26 weeks)
- Increasing risk with decreasing gestational age
serious ethical dilemmas
- Short notice decisions
- Need to balance maternal well-being against the
likely neonatal outcome
- Caesarean section in the babyrsquos interests
can rarely be justified prior to 25 weeks gestation
- Threshold viability infants should be followed up for
at least 2 years data collection
British Association of Perinatal Medicine Fetuses and newborn infants at the threshold of viability Pediatr 20021101024-27
Recommendations The American Academy
of Pediatrics bull 22-25 weeks gestation problematic
bull Non-initiation of resuscitation at 23 weeks (less 400g)
is appropriate
bull Difficulties in making accurate assessments before birth
bull Fetal weight can be inaccurate by 15-20
bull Small discrepancies in gestation of 1 or 2 weeks can have
major implications for outcome
bull Multiple gestation makes evaluation difficult
bull Counselling
bull But US legal trends restrict discretionary decision-making
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
The Marginally Viable Newborn Legal Challenges Conceptual Inadequacies and ReasonablenessSadath A Sayeed MD JD
The Journal of Law Medicine amp Ethics Volume 34 Issue 3 600-610 2006
Recommendations The Fetus and Newborn
Committee Canada
bull 22 weeks compassionate care only
bull 23-24 weeks careful consideration limited benefits and potential
harms of caesarean section and active resuscitation
bull Full care 25 weeks (survival rate is 50-80 with disability rates 10-25)
Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
MorbidityNuffields (GB)
bull 23 - 24 weeks gestation 64 risk of serious disability
bull At 25 weeks risk of severe disability 40
bull Each day increases survival by 3
bull Girls have a weekrsquos advantage over preterm boys
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
Morbidity Australia
bull Grey zone between 23-25 weeks + 6 days
bull Survival to discharge data
- 22w (0)
- 23w (29)
- 24w (50)
- 25w (65)
bull Proportion with no functional disability
23w (33) 24w (61) 25w (67)
Morbidity The Netherlands
Leiden follow up project data since 1983
Death or abnormal development
23-24 wks (92)
25 weeks (64)
26 weeks (35)
27-32 weeks (18)
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Rijken M et al Mortality and Neurologic Mental and Psychomotor Development at 2 Years in Infants Born less than 27 Weeks
Gestation The Leiden Follow-Up Project on Prematurity Pediatrics january 2003
Recommendations British Association of
Perinatal Medicine
22-28 weeks threshold of viability (under 26 weeks)
- Increasing risk with decreasing gestational age
serious ethical dilemmas
- Short notice decisions
- Need to balance maternal well-being against the
likely neonatal outcome
- Caesarean section in the babyrsquos interests
can rarely be justified prior to 25 weeks gestation
- Threshold viability infants should be followed up for
at least 2 years data collection
British Association of Perinatal Medicine Fetuses and newborn infants at the threshold of viability Pediatr 20021101024-27
Recommendations The American Academy
of Pediatrics bull 22-25 weeks gestation problematic
bull Non-initiation of resuscitation at 23 weeks (less 400g)
is appropriate
bull Difficulties in making accurate assessments before birth
bull Fetal weight can be inaccurate by 15-20
bull Small discrepancies in gestation of 1 or 2 weeks can have
major implications for outcome
bull Multiple gestation makes evaluation difficult
bull Counselling
bull But US legal trends restrict discretionary decision-making
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
The Marginally Viable Newborn Legal Challenges Conceptual Inadequacies and ReasonablenessSadath A Sayeed MD JD
The Journal of Law Medicine amp Ethics Volume 34 Issue 3 600-610 2006
Recommendations The Fetus and Newborn
Committee Canada
bull 22 weeks compassionate care only
bull 23-24 weeks careful consideration limited benefits and potential
harms of caesarean section and active resuscitation
bull Full care 25 weeks (survival rate is 50-80 with disability rates 10-25)
Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Morbidity Australia
bull Grey zone between 23-25 weeks + 6 days
bull Survival to discharge data
- 22w (0)
- 23w (29)
- 24w (50)
- 25w (65)
bull Proportion with no functional disability
23w (33) 24w (61) 25w (67)
Morbidity The Netherlands
Leiden follow up project data since 1983
Death or abnormal development
23-24 wks (92)
25 weeks (64)
26 weeks (35)
27-32 weeks (18)
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Rijken M et al Mortality and Neurologic Mental and Psychomotor Development at 2 Years in Infants Born less than 27 Weeks
Gestation The Leiden Follow-Up Project on Prematurity Pediatrics january 2003
Recommendations British Association of
Perinatal Medicine
22-28 weeks threshold of viability (under 26 weeks)
- Increasing risk with decreasing gestational age
serious ethical dilemmas
- Short notice decisions
- Need to balance maternal well-being against the
likely neonatal outcome
- Caesarean section in the babyrsquos interests
can rarely be justified prior to 25 weeks gestation
- Threshold viability infants should be followed up for
at least 2 years data collection
British Association of Perinatal Medicine Fetuses and newborn infants at the threshold of viability Pediatr 20021101024-27
Recommendations The American Academy
of Pediatrics bull 22-25 weeks gestation problematic
bull Non-initiation of resuscitation at 23 weeks (less 400g)
is appropriate
bull Difficulties in making accurate assessments before birth
bull Fetal weight can be inaccurate by 15-20
bull Small discrepancies in gestation of 1 or 2 weeks can have
major implications for outcome
bull Multiple gestation makes evaluation difficult
bull Counselling
bull But US legal trends restrict discretionary decision-making
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
The Marginally Viable Newborn Legal Challenges Conceptual Inadequacies and ReasonablenessSadath A Sayeed MD JD
The Journal of Law Medicine amp Ethics Volume 34 Issue 3 600-610 2006
Recommendations The Fetus and Newborn
Committee Canada
bull 22 weeks compassionate care only
bull 23-24 weeks careful consideration limited benefits and potential
harms of caesarean section and active resuscitation
bull Full care 25 weeks (survival rate is 50-80 with disability rates 10-25)
Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Morbidity The Netherlands
Leiden follow up project data since 1983
Death or abnormal development
23-24 wks (92)
25 weeks (64)
26 weeks (35)
27-32 weeks (18)
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Rijken M et al Mortality and Neurologic Mental and Psychomotor Development at 2 Years in Infants Born less than 27 Weeks
Gestation The Leiden Follow-Up Project on Prematurity Pediatrics january 2003
Recommendations British Association of
Perinatal Medicine
22-28 weeks threshold of viability (under 26 weeks)
- Increasing risk with decreasing gestational age
serious ethical dilemmas
- Short notice decisions
- Need to balance maternal well-being against the
likely neonatal outcome
- Caesarean section in the babyrsquos interests
can rarely be justified prior to 25 weeks gestation
- Threshold viability infants should be followed up for
at least 2 years data collection
British Association of Perinatal Medicine Fetuses and newborn infants at the threshold of viability Pediatr 20021101024-27
Recommendations The American Academy
of Pediatrics bull 22-25 weeks gestation problematic
bull Non-initiation of resuscitation at 23 weeks (less 400g)
is appropriate
bull Difficulties in making accurate assessments before birth
bull Fetal weight can be inaccurate by 15-20
bull Small discrepancies in gestation of 1 or 2 weeks can have
major implications for outcome
bull Multiple gestation makes evaluation difficult
bull Counselling
bull But US legal trends restrict discretionary decision-making
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
The Marginally Viable Newborn Legal Challenges Conceptual Inadequacies and ReasonablenessSadath A Sayeed MD JD
The Journal of Law Medicine amp Ethics Volume 34 Issue 3 600-610 2006
Recommendations The Fetus and Newborn
Committee Canada
bull 22 weeks compassionate care only
bull 23-24 weeks careful consideration limited benefits and potential
harms of caesarean section and active resuscitation
bull Full care 25 weeks (survival rate is 50-80 with disability rates 10-25)
Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Recommendations British Association of
Perinatal Medicine
22-28 weeks threshold of viability (under 26 weeks)
- Increasing risk with decreasing gestational age
serious ethical dilemmas
- Short notice decisions
- Need to balance maternal well-being against the
likely neonatal outcome
- Caesarean section in the babyrsquos interests
can rarely be justified prior to 25 weeks gestation
- Threshold viability infants should be followed up for
at least 2 years data collection
British Association of Perinatal Medicine Fetuses and newborn infants at the threshold of viability Pediatr 20021101024-27
Recommendations The American Academy
of Pediatrics bull 22-25 weeks gestation problematic
bull Non-initiation of resuscitation at 23 weeks (less 400g)
is appropriate
bull Difficulties in making accurate assessments before birth
bull Fetal weight can be inaccurate by 15-20
bull Small discrepancies in gestation of 1 or 2 weeks can have
major implications for outcome
bull Multiple gestation makes evaluation difficult
bull Counselling
bull But US legal trends restrict discretionary decision-making
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
The Marginally Viable Newborn Legal Challenges Conceptual Inadequacies and ReasonablenessSadath A Sayeed MD JD
The Journal of Law Medicine amp Ethics Volume 34 Issue 3 600-610 2006
Recommendations The Fetus and Newborn
Committee Canada
bull 22 weeks compassionate care only
bull 23-24 weeks careful consideration limited benefits and potential
harms of caesarean section and active resuscitation
bull Full care 25 weeks (survival rate is 50-80 with disability rates 10-25)
Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Recommendations The American Academy
of Pediatrics bull 22-25 weeks gestation problematic
bull Non-initiation of resuscitation at 23 weeks (less 400g)
is appropriate
bull Difficulties in making accurate assessments before birth
bull Fetal weight can be inaccurate by 15-20
bull Small discrepancies in gestation of 1 or 2 weeks can have
major implications for outcome
bull Multiple gestation makes evaluation difficult
bull Counselling
bull But US legal trends restrict discretionary decision-making
Stringer M Brooks PM et al New guidelines for maternal and neonatal resuscitation Journal of obstetrics
gynecology and neonatal nursing 2007 36(6) 624 -34
The Marginally Viable Newborn Legal Challenges Conceptual Inadequacies and ReasonablenessSadath A Sayeed MD JD
The Journal of Law Medicine amp Ethics Volume 34 Issue 3 600-610 2006
Recommendations The Fetus and Newborn
Committee Canada
bull 22 weeks compassionate care only
bull 23-24 weeks careful consideration limited benefits and potential
harms of caesarean section and active resuscitation
bull Full care 25 weeks (survival rate is 50-80 with disability rates 10-25)
Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Recommendations The Fetus and Newborn
Committee Canada
bull 22 weeks compassionate care only
bull 23-24 weeks careful consideration limited benefits and potential
harms of caesarean section and active resuscitation
bull Full care 25 weeks (survival rate is 50-80 with disability rates 10-25)
Fetus and newborn committee Canadian paediatric society maternal-fetal medicine committee society of obstetricians and
gynaecologists of Canada Management of the woman with threatened birth of an infant of extremely low gestational age
Can Med Assoc J 1994151547-53
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Recommendations The Netherlands
bull No intensive care to babies before 25-26 weeks gestation
bull Decisions should be taken with full participation of the parents
bull Unclear cutoff of resuscitation of immature infants
- at 25 50 or 75 chance of intact survival - (Viability not universally agreed thus if bar is set low there will be more
survivors with more handicaps)
bull Euthanasia institutionalised
Sheldon T Dutch doctors change policy on treating preterm babies BMJ 20013221383
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Recommendations Australia
bull Grey zone between 23-25 weeks + 6 days option of non-initiation of
resuscitation and intensive care reasonable
- obligation to treat increases as the gestation advances
- at 25 weeks active treatment is usually offered
- unless adverse circumstances
bull twin-twin transfusion
bull intrauterine growth restriction
bull chorioamnionitis
bull poor condition at birth or the presence of a serious abnormality
- at 26 weeks gestation the obligation to treat is very high
- non-directive counselling avoidance of over burdening parents
bull 24 weeks antenatal transfer to a tertiary centre with option of ldquoDNRrdquo
Aust N Z J Obstet Gynaecol 2007 Aug47(4)273-8Delivery in the grey zone collaborative approach to extremely preterm birth
Keogh J Sinn J Hollebone K Bajuk B Fischer W Lui K Consensus Workshop Organising Committee
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Malcom F Should artificial resuscitation be offered to extremely premature neonates AMSJ 2010 p 86-9
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Recommendations The Nuffield Council
on Bioethics (GB)
bull 23-26 weeks = grey area
bull 2 components
- to resuscitate and admit to the NICU
- to continue with intensive care or replace with
palliative care
bull Recommendations
- at 25 weeks and above institute intensive care
- 24-25 weeks offer intensive care unless different parentsrsquo wishes
- 23- 24 weeks clinicians should not be obliged to resuscitate
Nuffield Council on Bioethics Critical care decisions in fetal and neonatal medicine ethical issues
LondonNCB2006 wwwNuffieldbioethicsorggoourworkneonatalpublication 406html
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
ldquoNatural instincts are to try to save all babies even if
the babys chances of survival are low
However we dont think it is always right to put a baby
through the stress and pain of invasive treatment if the
baby is unlikely to get any better and death is
inevitable (Margaret Brazier professor of law at Manchester University)
Prolonging the life of profoundly sick premature babies
may be inhumane and place an intolerable burden on
the babyrdquo
treatment just prolongs the process of dyingrdquo
(Andrew Whitelaw professor of neonatal medicine at the University of Bristol UK)
Nuffield Council on Bioethics
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
The Nuffield Council on Bioethics
Medical ethics committee of the British Medical Association (BMA)
bull The report echoes existing best practicerdquo
bull Disagreement with stringent cut-off points for treatment
- The BMA believes that blanket rules do not help
individual parents or their very premature babiesrdquo
- Each case should be considered on its merits andin its
own contextrdquo
(Tony Calland)
When premature babies should be allowed to die Gaia Vince New scientist 15 November 2006
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Neonatal section of the Irish Faculty of
Paediatrics
bull Withdrawal of care appropriate in infants born within the
threshold period who fail to respond to initial intensive care
efforts or develop severe complications
bull Acceptable not to resuscitate newborns
under 500g andor under 24 weeks gestation
Neonatal subcommittee of the Irish faculty of Paediatrics Statement on perinatal care at the threshold of viability2006
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Recommendations France
bull Usually no resuscitation below 24 WGA
bull At 24 weeks particular attention to parentsrsquo wishes
bull Maximum degree of uncertainty on the real interest of the patient nobody can pretend to claim which is the best attitude
bull Other criteriae to be taken into account (discretional resuscitation)
bull Prenatal corticosteroids
Moriette G Rameix S et al groupe de reacuteflexion sur les aspects eacutethiques de la peacuterinatologie very premature births dilemmas and management Part 1 outcome of infants born before 28 weeks of postmenstrual age and definition of grey zone Archives de Peacutediatrie 2010 May17(5)518-26 part 2 527-39
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Recommendations Switzerland
bull lt 24 weeks palliative
bull gt 24 weeks according to the experienced neonatology
team
Swiss Society of Neonatology recommandations pour la prise en charge des preacutematureacutes agrave la limite de la viabiliteacute (22 - 26 SA) 2002
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Recommendations Ukraine
Gestation period lt 28 weeks
bull Define the exact gestational age and weightof the fetus estimate
prognosis provide further consultations recommendations and coordinate
team work of all members of perinatal team
bull Inform and discuss with future parents about medical and social risks and
peculiarities of resuscitation care providing for the newborn
bull Resuscitation is almost always provided if high survival chances and
acceptable morbidity
bull In case of doubtful prognosis necessity to support the wish of parents
bull Do not start the resuscitation of a newborn if almost 100 early death rate
likely (Ie gestation period lt 23 weeks weight lt 400 gr)
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Can limits be clearly defined Summary
- No international consensus = chance for avoidance of
systematic approaches
- CUTOFF borderline of viability
- 50 of mortality but disability difficult to objectify and use as a criteria
- All would resuscitate at 26 weeks most would not at 23 weeks
- Grey area 24 and 25 weeks gestation = 2 per 1000 births
- fetal weight 10 error
- gestational age 3 - 5 days error
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Can limits be clearly defined Outcome
estimation tool
Secondary criteriae
- Girls 1 week advantage
- Every day increases survival by 3
- Full course of antenatal steroids
- Level of unit
- Black race
- High-medium level of income of parents
- Multiple birth twin-to-twin transfusion
- Birth weight
- Babyrsquos condition at delivery
(chorioamnionitis increases the risk of periventricular leucomalacia)
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Time-frame algorythm for decision
making
bull Primary resuscitation YN
bull Proceed to intensive care or palliative care
bull Continue with option YN bull Euthanasia
ndash Netherlands (Groningen Protocol)
bull To motivate physicians to adhere to the highest standards of decision making
bull To reduce hidden euthanasia by facilitating reporting
bull Requires that all possible palliative measures be exhausted before euthanasia is performed
bull Might do more in mobilizing the availability of palliative care services than the current situation of unreported practice
ndash EURONIC 73 in 8 European Countries
Rebagliato M et al EURONIC study group Neonatal end-of-life decision making Physicianrsquos attitudes and relationships
with self-reported practices in 10 European countries The Journal of Medical Association 2000 Nov 15284(19)2451-9
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Acting in the ldquobest interests of the patientrdquo
bull degree of suffering involved in the care
bull futility of further intervention
bull likelihood of survival free of serious disability
and practical consequences
Legal - moral The Best Interests Standard
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
United Kingdom Court of Appeal1993
Doctors and parents may not undertake actions where the purpose is
to end life they may in appropriate circumstances use drugs to
relieve pain and distress even though their use may advance the time
of death
Palliative Care
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Palliative Care in France lois Leonetti (2005)
bull Legalises arrest of ldquonon-reasonable treatmentrdquo
bull Authorizes at the end of life the use of treatment for comfort
of patient (pain)
bull Taking into account that the treatment might shorten length of
survival
bull Always with the patientrsquos consent = parentrsquos consent
Recently French Medical Council expressed itself in the same terms
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
bull At birth neither certainty nor uncertainty as prognosis is clear-cut
(Self-fullfilling prophecy may be created by delays or suboptimal management)
bull Initiation of resuscitation leads to admission to NICU
- cascade of expensive uncomfortable or painful procedures
- raise parental expectations about survival
bull Denying intensive care a priori based solely on the age of
gestation or birth weight = contrary to the principle of equity
bull Decision-making after initial resuscitation (continue or withdraw
treatment) more justifiable
Decision-making for palliative care
Acta Paediatr 2008 Mar97(3)276-9 doi 101111j1651-2227200800663xCaregivers attitudes for very premature infants
what if they knewJanvier A Lantos J DeschIacutenes M Couture E Nadeau S Barrington KJ
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
bull Case-by-case basis according postnatal assessment
bull Factors always to be considered
- parents
- resources
- planned pregnancy
- assisted conception
- maternal age
- illness and fetal conditions
Decisions made by parents before birth are not necessarily
absolute and binding
Decision-making for intensive care
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Divorces after handicap
bull Nine times higher in case of spina bifida (BJ PSYCH 131 79-82
(1977) J Maulden Population studies vol 46 issue2 pages 349 362 (1992)
bull Low birth weight children in the US are at higher risk of experiencing
their parents divorce than children of normal birth weight
bull Not confirmed in British couples
Healthy Baby Healthy Marriage The Effct of Childrens
Health on Divorce Angela R Fertig Princeton University
288 Wallace Hall Princeton NJ 08544
afertigprincetonedu 609-258-5868 June 17 2004
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Ethics andhellipcorticosteroids
bull Antenatal corticosteroids
bull A technical medical ethical obligation
ndash No obstetrical or medical CI (infection hypertension)
ndash C Spencer K Neales Antenatal corticosteroids to prevent neonatal respiratory distress syndrome BMJ 2000 320 325 doi
101136bmj3207231325 (Published 5 February 2000)
ndash Roberts D Dalziel Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth The
Cochrane Database of Systematic Reviews 2010 Issue 8 Copyright copy 2010 The Cochrane Collaboration
ndash JV Been B W Kramer L J Zimmermann Antenatal corticosteroids to prevent preterm birt The LancetVol 373 Issue 9667 Page
894 14 March 2009
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Ethics andhellipcorticosteroids
bull Postnatal corticosteroids in BPD
ndash Increased risk of neurodevelopmental impairment growth retardation etc but faster extubation less PDA etchellip
ndash ldquoEthicallyrdquo contraindicated Early (lt 8 days) postnatal corticosteroids for preventing chronic lung disease in
preterm infants Henry L Halliday1 Richard A Ehrenkranz2 Lex W Doyle31Perinatal Room Royal-Jubilee Maternity Service
Belfast UK 2Department of Pediatrics Yale University New Haven Connecticut USA 3Department of Obstetrics and Gynaecology University of Melbourne Parkville AustraliaContact address Henry L Halliday Perinatal Room Royal-Jubilee Maternity Service Royal Maternity Hospital Grosvenor Road Belfast Northern
Ireland BT12 6BA UK Cochrane Neonatal Group
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Ethics andhellipiatrogenic diseases
- Environment in which the baby is managed (eg light noise touch)
- Mode of ventilation (eg conventional synchronized high-frequency)
- Types doses and results of medications used - Short-term and long-term effects of certain often
painful procedures - Foreign bodies or devices used - How the babys nutritional needs are met (enteral
parenteral nutrition) Developmental care for promoting development and preventing morbidity in preterm infants
Amanda J Symington1 Janet Pinelli2
1The Childrens Hospital Hamilton Health Sciences Hamilton Ontario Canada 2School of Nursing McMaster University Hamilton Canada
Cochrane Neonatal Group
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Ethics andhellippain
Opioids for neonates receiving mechanical ventilation
Roberto Bell˘1 Koert A de Waal2 Rinaldo Zanini31Neonatal Intensive Care Unit Ospedale Manzoni -Lecco Lecco
Italy 2Neonatology Academic Medical Centre Amsterdam Netherlands 3Neonatal Intensive Care Unit Ospedale
A Manzoni - Lecco Lecco ItalyContact address Roberto Bell˘ Neonatal Intensive Care Unit Ospedale
Manzoni -Lecco Via Eremo 9 Lecco 23900 Italy Editorial group Cochrane Neonatal Group
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care
unit
Eugene Ng1 Anna Taddio2 Arne Ohlsson31Department of Newborn and Developmental Paediatrics Sunnybrook
Health Sciences Centre Toronto Canada 2Graduate Department of Pharmaceutical Sciences Hospital for Sick
Children Research Institute Toronto Canada 3Departments of Paediatrics Obstetrics and Gynaecology and Health
Policy Management and Evaluation University of Toronto Toronto CanadaContact address Eugene Ng
Department of Newborn and Developmental Paediatrics Sunnybrook Health Sciences Centre CO Womens College
Hospital 76 Grenville Street Toronto Ontario M5S1B2 Canada Editorial group Cochrane Neonatal Group
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Ethics andhellipaesthetics
bull End-of-life comfortappearance for the
ndash Infant
ndash Parents
ndash Caregivers
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Ethics andhellipparents
bull Infant-parent emotional bonding
ndash Regionalisation
ndash Participation of parents in healing process
ndash Skin-to-skin
ndash Informed consent
ndash Decision making
Raines DA Parents values a missing link in the neonatal intensive care equation Neonatal Netw Apr 199615(3)7-12
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
When individuals lack decision-making capacityhellip
hellipthe interests and welfare of the patient take priority
over all other parties
hellipthe interests of the neonate are inextricably linked
to that of the parents
their interests must be taken into account empowering them to
decision-making
Parents
Kent AL et al Collaborative decision-making for extreme premature delivery J Paediatr Child Health 2007 43 489-91
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Parents recommendations
bull Counselling should initiate before delivery
bull Transparency openness and honesty
bull Favour frequent discussions with parents
bull Update them on
ndash their infants condition
ndash interventions that may be needed
bull Avoid confusing medical terminology as much as possible
bull Be honest and frank about the infants condition and prognosis even
on matters of uncertainty
bull Ask feed backs to ensure parents understand what is being discussed
Collaborative decision-making for extreme premature deliveryKent AL et al NSW and ACT Perinatal Care at the Borderlines
of Viability Consensus Workshop Committee J Paediatr Child Health 2007 Jun43(6)489-91
Caeymaex L ed al Journeacutees Parisiennes de Peacutediatrie 2008 Fin de vie en reacuteanimation neacuteonatale mieux
comprendre les attentes et le point de vues des parents
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Communication with parents
Montreal group
52 mothers in preterm labour all infants at
23 weeks gestation were resuscitated including
6 cases with conditional non-resuscitation instructions
Thus
- In acute situations the default mode is to treat
- To step back from action seems to be very difficult
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Some answers creation of guidelines
protocols
Not feeling alone ability to rely on the experience
and expertise of others is helpful
ndash Expertise
ndash Enabling
ndash Empowering
ndash Encouraging
ndash Education
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
A Case Method To Assist Clinical Ethics
Decision Making
(Modified from American College of Physicians Ethics Manual)
bull 1 Define the ethics problem as an ought or should question (eg Should we withhold a respirator for this
extremely preterm baby 25 WGA as his parents request)
bull 2 List relevant facts and uncertainties Include facts about the patient and caregivers (such as emotional state cultural
background and legal standing) Include physiologic facts and significant medical uncertainties (such as expected
outcomes with and without treatment) and the benefits and harms of treatment options
bull 3 Identify a decision maker If the patient is competent the decision maker is the patient If the patient is
incompetent identify a proxy decision maker (eg as specified by court appointment state law a durable power of
attorney for health care living will or the next of kin)
bull 4 Give understandable relevant desired information to the decision maker and dispel misconceptions
bull 5 Solicit values of the patient that are relevant to the question These include the patients values about life relation to
community and health care institutions goals for health care and conditions that would change goals and preferences
about health care or proxy decision makers
bull 6 Identify health professional values including health goals (such as prolonging life and alleviating pain) values that
pertain to patient physician communication (such as truth telling and confidentiality) and some values that extend
outside of the patient physician relationship (such as promotion of public health and respect for the law)
bull 7 Propose and critique solutions including options for treatment and alternative providers
bull 8 Identify and remove or address constraints on solutions (such as unavailability of services laws or legal myths)
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Recommendations
bull Define yourself your borderline between viability
according to capacities of your facilities
ndash Neurological outcomes
ndash Respiratory outcomes
ndash Caloric intake
Catlin A Carter B Creation of a neonatal end-of-life palliative care protocol J PerinatolApr-May 200222(3)184-95
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Much more researchhellip
bull Sociological
bull Interviews of implicated persons
bull Stratification
bull EURONIC
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
Conclusion bull Grey zones are grey
bull It is likely they will stay grey for some time
bull It would be an error to wash them white or darken them
bull Grey zones have to be adapted to the local contexts
bull Every wardhospitalmaternity should allow open discussions have a
committee on ethics establish internal guidelines
bull The role of the parents in decision-making after as-objective-as-
possible information given by healthcare members is essential
bull Making ethical decisions might be very difficult but ethical
relationships with the preterm and his parents can compensate this
