Engmann: Prevention and Care for Babies Born Too Soon

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Prevention and Care for BabiesBorn Too SoonGlobal Newborn Health ConferenceJohannesburg, South Africa

April 16, 2013

Cyril M. Engmann MD FAAP

Senior Program Officer, Neonatal HealthMaternal, Newborn and Child Health ProgramBill & Melinda Gates Foundation


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Outline

Preterm burden

Implementation & research horizons

Purpose-driven, catalytic partnerships

EVERY PERSON, INCLUDING NEWBORNSDESERVES THE CHANCE TO LIVE A HEALTHY,PRODUCTIVE LIFE.

2 2013 Bill & Melinda Gates Foundation |


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Note: rates by country are available on the accompanying wall chart. Not applicable=non WHO Members StateSource: Blencowe et al National, regional and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications

15 Million Preterm births a global problem

PRETERM BIRTH: BIRTH BEFORE 37 COMPLETED WEEKS OF GESTATION

10 countriesaccount for 60%

of the worlds

preterm births

1. India2. China3. Nigeria

4. Pakistan5. Indonesia6. United States

of America7. Bangladesh8. Philippines9. Dem Rep

Congo10. Brazil


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Preterm birth also a major issue in high-income countries

United States among top tencountries in terms of number of

preterm birthsPreterm birth costs developed

world ~$40B per year

IOM report from 2007 found that pretermbirth cost the US $26.2B per year1

Extrapolating to rest of developed worldbased on per-capita HC spend and PTbirth rate suggests cost of ~$40B annually

Creates unique opportunity to leverage investments & learning from low- andmiddle- and high-income countries to improve preterm birth and newborn health

1. Includes costs of medical care services, early intervention services, special education services, and lost household and labor market productivity. Methods: total economic cost associated with 1preterm baby estimated to be $51,600 in the US in 2005 (Behman et al). Estimate for other countries obtained by scaling each country's per capita health expenditure in 2005 to that of the US. Totaleconomic cost saved for a given country is cost per PTB infant x projected number of preterm births averted . Total sum here for all 42 UN high human development index countries (in green).Source: World Bank statistics, Behrman et al. (2007) Institute of Medicine: Preterm Birth: Causes, Consequences, and Prevention, Born Too Soon; BCG analysis

2010 preterm births ('000)

748

774

3,519

1,172

0

Nigeria

China

India

Pakistan

Indonesia

USA

Bangladesh

Philippines

Dem Rep Congo

Brazil

1,000 3,0002,000 4,000

676

517

424

349

341

279


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1.1 million preterm deaths each year

> 125 deaths per hour = Commercial liner crashing every 3 hours

2013 Bill & Melinda Gates Foundation | 5April 16, 2013


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Neonatal mortality is declining slower than childmortality and prematurity is the 2nd leading causeof under-5 deaths

Source: Lawn J E et al. Health Policy Plan. 2012;27:iii6-iii28; Liu L et al. Lancet.2012; 79(9832):2151-61.

Neonatal mortality is not dropping as fastas under-five mortality

2010 Childhood Mortality40% Neonatal PeriodPreterm birth is the #2 causeof U5 death

Other

27%

Preterm

15%

35%

23%

Infection

Intrapartum

Under 5 Mortality Neonatal Mortality

Infection includes: sepsis, pneumonia, tetanus and diarrhea


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Long-term impact of preterm birthon survivors

2013 Bill & Melinda Gates Foundation | 7

Long-term outcomes

Specific physical effects Visual impairment Hearing impairment Chronic lung disease of prematurity

Long-term cardiovascular ill-health andnon-communicable disease

Neuro-developmental/behavioral effects

Mild: disorders of executive functioning Moderate to severe: global developmental

delay

Psychiatric/behavioral sequalaeFamily, economic and societaleffects

Impact on family Impact on health service Intergenerational


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Born Too Soon The Global Action Report on

Preterm Birth


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Born Too Soon - a truly global report

First global estimates of preterm birth rate for184 countries with WHO (Lancet, 2012)

> 50 partner organizations including

45 authors from 11 countries includingscientists, epidemiologists, clinicians, parents

Linked to Every Woman Every Child, andforward by UN Secretary General Ban Ki-Moon

Free at www.who.int/pmnch/media/news/2012/preterm_birth_report/en/index.html

Professionals, policymakers and parents

http://www.who.int/pmnch/media/news/2012/preterm_birth_report/en/index.htmlhttp://www.who.int/pmnch/media/news/2012/preterm_birth_report/en/index.html


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Two groups formed to channel momentumfrom Born Too Soon into actionable steps

10

Research Group

Purpose: Develop a pretermresearch solution pathway

Core Conveners: NICHDGAPPS, MOD, BMGF, WHO@ Researchers

Next steps: Convene a

funders meeting in summer2013 to coordinate globalpreterm funding efforts

Care Group

Purpose: Accelerateimplementation of priorityinterventions

Core Members: UNICEF,WHO, SNL, USAID, BMGF,CIFF, AAP/IPA, PMNCH

Next steps: Efforts feedinginto Global Newborn

Actionwith a Plan to be

launched later this year

2013 Bill & Melinda Gates Foundation |


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What: A global movement to accelerate access to simple, cost-effective solutions, andsupport families who have experienced preterm birth.

Who: > 55 global partners and > 60 countries, all continents, media reach of 1.4 billion

High income countries, e.g. Illumination Initiative for famous buildings

Malawi: high level event, commitment made

Uganda: high level event with Minister of Health, commitment made for

KMC and ACS scale up

India: Global KMC meeting in Ahmedabad, India, etc

www.facebook.com/worldprematurityday

#Borntoosoon

#WorldPrematurityDay

Global twitter relay

28 million reached
http://www.facebook.com/worldprematuritydayhttp://www.facebook.com/worldprematurityday


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Outline

Preterm burden

Implementation &research horizons

Purpose-driven, catalytic partnerships



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Priority interventions -'tip of the spear' todrive maximal impact

ANCS

KMCNeonatal

resuscitation

Infection case

management

CPAP / novel

surfactant

Utilize high impact

priority interventions

to drive a wedge...

...for other critical

interventions to be

implemented in a

package...

...and to provide the

platform for implementing

future innovations

Cervical

pessary


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Kangaroo mother care

Skin-to-skin with mother 24 hours a day providing:

Exclusive breastfeeding

Supportive care for the mother infant dyad

Improved mortality (LMIC: RR 0.58, 95% CI 0.37-0.9 @ 40/41 or discharge)

Reduced infections (LBW: 7.2% vs. 12.6% RR 0.57, CI: 0.4-0.8 @ 6/12)

Improved infant growth (Weight: MD 3.9g/day; Length: MD 0.29cm/day; HC:0.18cm/week)

Reduced hypothermia (RR 0.23, 95% CI 0.1-0.55)

Mothers more likely to breastfeed @ 3/12 (RR 1.2, 95% CI 1.01-1.43)

Earlier discharge (2.4 days on average)

Increased maternal infant attachment (24 vs. 18)Effective entry point for care of small babies

Lawn et al Kangaroo mother care to prevent neonatal deaths due to preterm birth complications. Int J Epid: 2010,Conde-Agudelo A, Belizan JM, Diaz-Rossello, Cochrane Review: 2011

Could save an estimated 450,000 babies by 2015if 95% of preterm babies are reached


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We are working to overcome barriers towider use of Kangaroo Mother Care

Barrier Action

Factional and uncoordinated globalcommunity. ? Over-medicalization bythe medical profession, creating theperception that KMC is so hard,babies are so fragile, KMC must be

done just right, and are babiessafe resulting in making KMC so

complex

Conduct faction analysis, partner landscaping and apply a systemsapproach

Catalyze coordinated thinking, communication and action amongpartners, and align around common goals

Elaborate the fact base for KMC and identify points of alignment

vs. points of contention

Lack of cohesive national policieswith quality control and M&Ecomponents

Integrate recordkeeping and reporting on KMC into routinemonitoring and evaluation systems

Countries self-selected to become champions

Lack of integration - KMC oftenlimited to referral centers

Promote a KMC continuum of care culture and framework

Limited demand among families forpostnatal services

Promote early care-seeking through community engagement Understand social support needs of moms and families to practice

KMC

Sources: MCHIP, Save the Children (2012). Tracking Implementation Progress for Kangaroo Mother Care.


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Groundswell of newborn community askingquestions of KMC and building momentum

WHO CHNRI Exercise, KMC was Top of the list for preterm birth questions

Among top 10 newborn research priorities

Evaluate the effectiveness, safety and cost of community-based initiationof KMC to improve survival and health outcomes of clinically stable

preterm and LBW babies

Evaluate strategies for scale up of facility-based initiation of KMC for

preterm and LBW babies on their survival, health and long-term

outcomes such as school-performance



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We are working to overcome contextualbarriers to wider use of antenatalcorticosteroids


Barrier Action

Lack of awareness,knowledge, guidelines & localregulations about who canadminister drug; lack ofand/or belief among

healthcare providers

Application to add to WHO Essential Medicines List Policy brief for use at country level Frequently asked questions to dispel myths Online portal for quick reference to key information In-country education and training

Lack of supply at the rightplace and right time

Identification of multiple, low cost (


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We are working with research and funding partnersto map out a preterm solution pathway to coordinateour efforts Research group

Discovery Development Delivery

ProgesteroneRequires tools to enable deployment &

user friendly formulation

Cervical pessaryVery promising but requires validation

and tools to enable deployment

Institutional KMCRequires effort to drive uptake

CPAPRequires adaptation for

use in low resource settings

Novel surfactantRequires more user

friendly & inexpensive formulation

Prevent

preterm

births

Careforthe

pretermb

aby

Predict

pretermb

irths Understand

etiopathogenesisof PTB &develop

interventions to

predict andprevent PTBs

Requires clearly

defined research

agenda and more

traction from research

and funding

communities

Cervical length measurementRequires dev of suitable methods for


PTB biomarkersRequires validation of high potential

options and dev. of field ready Dx

Fetal FibronectinMainly used to rule out PTB,

has low positive predictive value

Assessment of prior PTB hxRequires dev. of suitable methods for


Antenatal CorticosteroidsRequires effort to drive uptake

Community KMCBeing implemented in select locations but still requires

more operational research before widespread uptake

Socialfactors

e.g. stress

Care group



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Preterm birth research horizons tofill the gaps of known interventionsBiomarkers, proteomics, pessaries, progesterone.



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First published RCT assessing use of cervicalpessary in PTB showed efficacy on all end points

Women with cervical length 25mm

randomized to pessary or control

Meaningful efficacy seen on all

pregnancy and neonatal outcomes

Relative Risk

Composite

1.00.50.0

Sepsis Rx

RDS

BW < 2500 g

BW < 1500 g

PTB < 37 wksPTB < 34 wks

PTB < 28 wks 0.25 [0.09-0.73]

0.24 [0.13-0.43]

0.36 [0.27-0.49]

0.35 [0.17-0.72]

0.30 [0.18-0.50]

0.22 [0.08-0.56]

0.25 [0.07-0.87]

0.17 [0.07-0.42]

Pregnancy

Neonatal

Source: Goya et al. Lancet (2012): Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial, Data from Goya et al study convertedinto relative risk and 95% CI using online calculator from Centre for Evidence Based Medicine, Toronto which is accessible at http://ktclearinghouse.ca/cebm/practise/ca/calculators/statscalcBCG analysis

While impressive, consensus is that more trials are needed to confirm RCT findings

726 women withcervix 25mm

192 assigned tocervical pessary

193 assigned toexpectant mgt.

190 included inintention-to-treat

analysis

190 included inintention-to-treat

analysis

341 opted out

2 lost to follow up 3 lost to follow up

385 randomlyassigned
http://ktclearinghouse.ca/cebm/practise/ca/calculators/statscalchttp://ktclearinghouse.ca/cebm/practise/ca/calculators/statscalc


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Cochrane meta-analysis by Dodd et al. showed benefit ofprogesterone1 in women with different PTB risk profiles

1.0

Relative Risk

0.8

PTB < 37 wks

0.60.40.20.0

Risk of tocolysis

Neonatal sepsis

BW < 2500 g

PTB < 37 wks

PTB < 34 wks

PTB < 34 wks

Short cervix2

PTB history

Multiple pregnancy

RR 0.58 [0.38-0.87]

RR 0.28 [0.08-0.97]

RR 0.15 [0.04-0.64]

RR 0.80 [0.70-0.92]

RR 0.64 [0.49-0.83]

RR 0.75 [0.57-0.97]

Threatened PT laborRR 0.29 [0.12-0.69]

[95% CI]

1. Cochrane review did not differentiate between subtypes of progesterone (natural progesterone vs. synthetic 17-alpha-hydroxyprogesterone caproate (17P)). 2. Short cervix definition varies, andCochrane review included only cervical length < 15 mmSource Dodd et al. Cochrane Library (2012), Romero. Women's Health (2011), BCG analysis


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The late preterm @ 32-36 weeks (85% of PTB) moreprone to adverse effects than @ 40 weeks


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Outline

Preterm burden

Implementation & research horizons

Purpose-driven, catalyticpartnerships



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We cannot view newborn health inisolation. We must take a holistic,

panoramic view involving catalyticpartnerships

Partnerships can lead

to better, faster,greater healthoutcomes within the

context of healthy andproductive families



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What Can You Do?

1. Policy: include newborn and preterm birth in policyframeworks

2. Program: ANCS & KMC; measure, quality of care

3. Form purpose-driven partnerships: across RMNCH,nutrition, malaria, education

2013 Bill & Melinda Gates Foundation | 25April 16, 2013


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The task is not impossible



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A single spider weaves

a web and catches one fly,

Many spiders weave a web and

catch an elephant.

-Ghanaian proverb


Documents

Engmann: Prevention and Care for Babies Born Too Soon