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Journal club discussionSep

2014

Jegen Kandasamy MD

PGY-6, NPM


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In the NICU rates of healthcare associated infections are at least as high as

25%


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Several studies have shown that skin underneath rings is moreheavily colonised than comparable areas of skin on fingers withoutrings.

Wearing rings increases the carriage rate of gram negative bacteriaand enterobacteriaceae on the hands of HCWs.

Hand hygiene policies and education should include a section onappropriate jewellery to be worn in the workplace.

The consensus recommendation from WHO is to stronglydiscourage the wearing of finger and wrist jewellery duringhealthcare

The wearing of a simple flat band during routine care may beacceptable, but in high risk settings all rings or other jewelleryshould be removed

On average each neonate or his or her immediate environment wastouched 78 times per shift.


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Is hand hygiene alone sufficient? Waters et al, Clin Infect Dis, 2004

To characterize the molecular epidemiology of gram-negative bacilli (GNB)causing infections in infants and associated with carriage on nurses' handsafter hand hygiene was performed

Overall, 58% of infections were caused by unique strains not cultured fromother infants or nurses, and 31% of infections were part of unrecognizedmolecular clusters

In contrast, only 9% of strains that caused infections were cultured fromnurses' hands

These data suggest that practices in addition to hand hygiene are needed toprevent horizontal transmission of GNB in the NICU

Cohen et at, Pediatr Infect Dis J, 2003 Despite appropriate hand hygiene cultures from the hands of medical staff

yield microbes more than 50% of the time

Standard hand hygiene lowers the number of microbes on HCPs hands

and eliminates transient flora, but permanent flora may persist


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Is hand hygiene alone sufficient?

Pessoa-Silva, Infect Control Hosp Epidemiol,

2004 HCWs who did not wear gloves acquired, on average, 24.5 CFU/min as compared with

-1.9 among those who did


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Previous studies

Ng et al, ADC FN edition, 2004 To assess the incidence of late onset sepsis and NEC in

VLBW infants in two 36 month periods using two handhygiene protocols: conventional handwashing (HW; first 36month period); an alcohol hand rub and gloves technique(HR; second 36 month period)

Retrospective review of period prior to institution of newhand hygiene protocol

ABHR, glove, ABHR for gloves

The introduction of the HR protocol was associated with a2.8-fold reduction in the incidence of LOS, and also asignificant decrease in the incidence of MRSA septicaemiaand NEC in VLBW infants


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Study premise

Preventing infections is critical to improvingrates of survival without neurodevelopmentalimpairment and decreasing duration of

hospital stays and costs in this population Although hand hygiene infection control and

prevention measures have been the topics ofmultiple epidemiologic and retrospectivestudies, they have not been subjected torandomized clinical trials in the NICU


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JAMA PediatricsGlove Use to Prevent Infections in

Preterm Infants

Kaufman DA, Blackman A, Conaway MR, Sinkin RA. Nonsterileglove use in addition to hand hygiene to prevent late-onsetinfection in preterm infants: randomized clinical trial.JAMAPediatr. Published online August 11, 2014.doi:10.1001/jamapediatrics.2014.953.


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Study Objective To determine if non-sterile glove use after hand

hygiene before all patient and intravenous

catheter contact, compared with hand hygienealone, prevents late-onset infections in preterm

infants.

Hypothesis: Glove use + hand hygiene will

decrease incidence of LOS and NEC compared toonly hand hygiene

Objective of the study


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Study Design

Prospective, single-center, randomized clinical trial. Infants randomized to into one of the two groups using block

randomization with randomly varying block sizes of 2 and 4 Minimum duration of 4 weeks after birth, extended until patient no

longer has venous access (central or peripheral) If lines were removed and subsequently required in future infant

reassigned to original group

Setting Neonatal intensive care unit with 50 bed spaces divided among 7 pods

Participants Birth weight


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Methods

Independent of group assignment, all health careprofessionals followed the 5 moments of hand hygiene from the World Health

Organization guidelinesfor hand hygiene in health care

used nonsterile gloves for contact with body fluids or whenaccessing arterial lines

used sterile gloves for aseptic procedures

Group B Hand hygiene was defined as using alcohol hand rub or washing

hands with antimicrobial soap (eg, 2% chlorhexidine gluconate)

Group A: Group B intervention plus use of non-sterilegloves No mention of ABHR use after donning non-sterile gloves


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Methods

Study intervention The study intervention was nonsterile glove use after hand hygiene

(group A) or hand hygiene alone (group B) prior to all patient, bed,and/or catheter contact.

Signs were placed on a stand at the bedside of all enrolled patients

(with a box of gloves if in group A) indicating group assignment andprotocol.

Intervention was specified to be performed during all contact with thepatient, inside the bed area, and with all central and peripheralvenous catheters.

Contact with central and peripheral catheters was defined aswhenever there was catheter contact and when making or breaking aconnection with the hub when

giving medications or flushes

changing tubing

accessing an injection port

adding a device


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Methods

Additional infection control and prevention practices in their NICUincluded

a CLABSI bundle for placement, maintenance, and removal ofcatheters;

fluconazole prophylaxis for all infants who weighed less than 1000 g at

birth and/or had a gestational age of less than 28 weeks, or any infantwith NEC or gastroschisis;

antibiotic stewardship including limited use of third- and fourth-generation cephalosporins and carbapenems;

limited use of postnatal corticosteroids, histamine H2receptorblockers, and proton pump inhibitors;

weekly changing of all nasogastric and orogastric tubes.

All patients with NEC in both groups were placed in contactisolation in which gowns and nonsterile gloves were used whilepatients were receiving antimicrobials.


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Outcomes

Primary 1 episode of late-onset (>72 hours of age) infection in the

bloodstream, urinary tract, or cerebrospinal fluid ornecrotizing enterocolitis that was treated with antibiotics

NEC was stage II or greater according to modified Bells

criteria Secondary

Length of hospital stay Infection-related outcomes Mortality Other neonatal morbidities

Cost of hospitalization


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Statistical methods

Sample size calculation Sample size of 120 infants

Study would have a 2-sided type I error rate of .05 or less and at least80% power to detect an absolute difference of 25% in the cumulativeincidence of late-onset infection, including NEC, between the 2 groups

Given a pretrial incidence of 60% based on local and national data Statistical methods

The 2test was used to compare categorical outcomes betweengroups

The nonparametric Mann-Whitney test was used to comparecontinuous outcomes

Poisson regression using the appropriate number of days (line days orstudy days) as the offset was used to compare the groups with respectto rates per 100 days.


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Methods

Limitations

Single-center study and may be affected by local infectioncontrol practices.

Sample size was based on a higher incidence of infectionsthan were observed in the control group, so it was

underpowered for the primary outcome. Aim of study was to have >90% compliance with hand

hygiene rates.

Parents had the choice to use gloves or not use gloves iftheir child was randomized to group A (group with

nonsterile glove use after hand hygiene). There is a possibility that if hand hygiene, glove use by

parents, and study protocol compliance were higher,infection rates may have been lower in 1 or both groups.


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Results


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Results


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Results

Difference inProportions

Between GroupsWith 95% CIs


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Comment

Nonsterile glove use after hand hygiene prior to patientand catheter contact is associated with fewer gram-positive bloodstream infections (BSIs) and central lineassociated bloodstream infections (CLABSIs) in this

group of preterm infants.

Number needed to treat: To prevent 1 gram-positive BSI is 6.

To prevent 1 possible CLABSI is 7.


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Comment

In addition to the Centers for Disease Control andPrevention definition of CLABSI, we also evaluatedpossible CLABSIs defined as detection of growth from 1blood culture of any organism, including coagulase-negative Staphylococcus,and the presence of a central

catheter in the absence of another source.

We included this definition because asymptomatic BSIs,defined as growth in 1 blood culture and treated, evenwhen caused by coagulase-negative Staphylococcusorganisms, are associated with increasedneurodevelopmental impairment and white matterinjury in preterm infants.


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Comment Retrospective studies have demonstrated an association with the

addition of glove use after hand hygiene in preterm infants andother patient populations.

Very low-birth weight infants: Decreased BSIs and necrotizingenterocolitis in preterm infants with birth weight


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Comment

This readily implementable infection control measure mayresult in decreased infections in high-risk preterm infants.

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