Plastic Bags for Prevention of Hypothermia inPreterm and Low Birth Weight Infants

WHATS KNOWN ON THIS SUBJECT: Preterm neonates inresource-poor settings frequently develop hypothermia. Plasticbags or wraps are a low-cost intervention for the prevention ofhypothermia in infants in developed countries.

WHAT THIS STUDY ADDS: For preterm infants born in a resource-poor health facility, placement in a plastic bag at birth can reducethe incidence of hypothermia at 1 hour after birth.

abstractBACKGROUND AND OBJECTIVES: Hypothermia contributes to neonatalmortality and morbidity, especially in preterm and low birth weightinfants in developing countries. Plastic bags covering the trunk andextremities of very low birth weight infants reduces hypothermia. Thistechnique has not been studied in larger infants or in many resource-limited settings. The objective was to determine if placing pretermand low birth weight infants inside a plastic bag at birth maintainsnormothermia.

METHODS: Infants at 26 to 36 weeks gestational age and/or with a birthweight of 1000 to 2500 g born at the University Teaching Hospital inLusaka, Zambia, were randomized by using a 1:1 allocation and paralleldesign to standard thermoregulation (blanket or radiant warmer) careor to standard thermoregulation care plus placement inside a plasticbag at birth. The primary outcome measure was axillary temperaturein the World Health Organizationdened normal range (36.537.5C) at1 hour after birth.

RESULTS: A total of 104 infants were randomized. At 1 hour after birth,infants randomized to plastic bag (n = 49) were more likely to havea temperature in the normal range as compared with infants in thestandard thermoregulation care group (n = 55; 59.2% vs 32.7%; relativerisk 1.81; 95% condence interval 1.162.81; P = .007). The temperatureat 1 hour after birth in the infants randomized to plastic bag was 36.56 0.5C compared with 36.1 6 0.6C in standard care infants (P ,.001). Hyperthermia (.38.0C) did not occur in any infant.

CONCLUSIONS: Placement of preterm/low birth weight infants insidea plastic bag at birth compared with standard thermoregulation carereduced hypothermia without resulting in hyperthermia, and is a low-cost, low-technology tool for resource-limited settings. Pediatrics2013;132:17

AUTHORS: Alicia E. Leadford, MD,a Jamie B. Warren, MD,MPH,b Albert Manasyan, MD,a,c Elwyn Chomba, MD,d

Ariel A. Salas, MD,a Robert Schelonka, MD,b andWaldemar A. Carlo, MDa,c

aUniversity of Alabama at Birmingham, Birmingham, Alabama;bOregon Health & Science University, Portland, Oregon; cCentrefor Infectious Disease Research in Zambia, Lusaka, Zambia; anddUniversity Teaching Hospital, Lusaka, Zambia

KEY WORDShypothermia/prevention and control, infant newborn, infantpremature, diseases/prevention and control, perinatal care/methods

ABBREVIATIONWHOWorld Health Organization

Dr Leadford conceptualized and designed the trial, implementedand carried out data collection, analyzed and drafted the initialpaper, and revised the nal manuscript; Dr Warren designed thetrial, and implemented and conducted data collection; DrManasyan designed, implemented, and carried out datacollection; Drs Chomba and Schelonka designed the trial; DrSalas designed the trial and conducted the analysis; Dr Carloconceptualized and designed the trial, analyzed the results,drafted the initial paper, and revised the nal manuscript; andall authors reviewed and approved the nal manuscript assubmitted.

This trial has been registered at www.clinicaltrials.gov(identier NCT01403623).

www.pediatrics.org/cgi/doi/10.1542/peds.2012-2030

doi:10.1542/peds.2012-2030

Accepted for publication Mar 19, 2013

Address correspondence to Waldemar A. Carlo, MD, University ofAlabama at Birmingham, 1700 6th Ave South, 176F Ste 9380,Birmingham, AL 35249-7335. E-mail: wcarlo@peds.uab.edu

PEDIATRICS (ISSN Numbers: Print, 0031-4005; Online, 1098-4275).

Copyright 2013 by the American Academy of Pediatrics

FINANCIAL DISCLOSURE: The authors have indicated they haveno nancial relationships relevant to this article to disclose.

FUNDING: Supported by grants from the Eunice Kennedy ShriverNational Institute of Child Health and Human Development GlobalNetwork for Womens and Childrens Health Research(HD043464), Perinatal Health and Human Development ResearchProgram of the University of Alabama at Birmingham, andChildrens of Alabama Centennial Scholar Fund. Funded by theNational Institutes of Health (NIH).

PEDIATRICS Volume 132, Number 1, July 2013 1

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Annually, about 3 million infants dieduring the neonatal period worldwide.1

More than 80% of these neonataldeaths can be attributed to infection,birth asphyxia, complications of pre-mature delivery, including hypothermia,and congenital anomalies.2 Hypother-mia has long been recognized as a se-rious risk to newborns, especiallypremature and low birth weightinfants,36 and is a problem in both thedeveloped7 and the developingworld.1,810

Neonatal hypothermia has been asso-ciated with increased risk of infection,coagulation defects, acidosis, delayedfetal-to-newborn circulatory adjustment,hyaline membrane disease, brain hem-orrhage, increased oxygen consumption,and increased mortality.3,5,1113 Infantsare most at risk for hypothermia in therst few minutes to hours after birth,when they are rst removed from thethermally regulated intrauterine envi-ronment.5,12,14 Hypothermia can occur ininfants of all countries, including tropicalclimates.8,9,15,16

The World Health Organization (WHO)recommendations to prevent hypo-thermia include a warm delivery room(25C), immediate drying, and re-suscitation under radiant warmers,skin-to-skin contact with the mother, oran incubator.17 Low-cost technologiesused to prevent hypothermia in pre-term and very low birth weight infantsin the developed world could be ex-tended to the developing world.

Evaporativeheat loss is themajorcauseof heat loss in newborn infants duringthe rst 30 minutes after birth.18 In-sensible water loss and an immatureskin barrier contribute to the increasedrisk of hypothermia in infants.5,19 Poly-ethylene occlusive wrapping or plasticbags used at birth in the delivery roomreduce hypothermia in extremely lowand very low birth weight infants.2024 Itis thought that plastic bags reduceevaporative/convective heat losses, in-sensible water loss, and the need for

metabolic heat production.17,25,26 McCallet al,27 in a Cochrane review (including 3studies of polyethylene wrappings usedwithin 10 minutes of birth in infants,32 weeks gestation), concluded thatthe use of plastic wraps or bagsdecreases hypothermia soon after birthand recommended future research todetermine the feasibility of their use inpoorer countries where cost is a con-cern. The Neonatal Resuscitation Pro-gram recommends the use of a plasticbag as a means to prevent hypothermiain infants born at,29weeks gestation.28

The International Liaison Committee onResuscitation consensus statement rec-ommends the use of a plastic bag inaddition to standard techniques in thedelivery room for very low birth weightinfants.29

Plastic bags may be an affordable op-tion for developing countries. The cur-rent trial was designed to test thehypothesis that use of low-cost plastic(polyethylene) bags starting at birthreduces hypothermia without causinghyperthermia at 1 hour after birth inpreterm and low birth weight infants.This trial enrolled more mature andlarger infants than previously studiedbecause in resource-limited settingsthese infants are at high risk of hypo-thermia.

METHODS

Study Design

In this single-center randomized con-trolled trial conducted at the tertiaryUniversity Teaching Hospital in Lusaka,Zambia, a standard thermoregula-tion care strategy (control group) wascompared with a strategy includingstandard thermoregulation care plusplacement of the newborn in a low-costpolyethylene bag (intervention group).The study was approved by the in-stitutional review boards of the Uni-versity of Alabama at Birmingham,Oregon Health & Science University,and University Teaching Hospital in

Lusaka, Zambia (Clinicaltrials.gov iden-tier NCT01403623).

Infants born at the hospital were eli-gible for inclusion if they were between26 weeks 0 days and 36 weeks 6 days ofgestation at birth according to the bestobstetrical estimate (using last men-strual period, fundal height, and ul-trasound as assessed by the obstetricteam) or if their birth weight was be-tween 1000 and 2500 g. Infants wereexcluded if they had an abdominal walldefect, myelomeningocele, other majorcongenital anomaly, or obvious skindisorders. Mothers of eligible infantswere identied on admission to thelabor and delivery unit and approachedfor consent before delivery or within 10minutes after delivery if previous con-sentwasnot possible.Written informedconsent from the mother was obtainedfor each infant. Enrollment occurredfrom August through October 2011.Infants were randomized during bothday and night shifts.

In a 1:1 allocation and parallel design,infants were randomly assigned to 1 ofthe 2 treatment groups at birth. Ran-domization occurred at birth or withinthe rst 10 minutes after birth. Twinsand higher-order multiples were ran-domized individually. Randomizationwas blinded and done by using sealednumbered envelopes assigned by arandom number generator. Study in-vestigators kept the sealed envelopesand opened them at the birth of theinfant. Blinding of the intervention wasnot possible.

The University Teaching Hospital inLusaka is a tertiary referral, teachinghospital in the capital of Zambia. Thereare approximately 11 000 to 13 000annual births, almost exclusively fromhigh-risk referrals. The ward is staffedby midwives, obstetrics-gynecologyresidents, and attending obstetricians.There is ultrasound and cesarean de-livery capability. Electronic fetal moni-toring during labor is not available.

2 LEADFORD et al

There is a NICU staffed by dedicatednurses, pediatric residents, pediatricians,and neonatologists. There are nearly3000 preterm and term infants admit-ted annually to the NICU, with a mor-tality rate of 40%. There is incubator,radiant warmer, intravenous uid, ox-ygen supplementation, ventilator, andintravenous medication capability. Thenursery and NICU have space heatersto achieve a goal room temperature of25C, but this is difcult to maintainwith open doors and windows. Lusakahas a tropical climate close to the equa-tor, but has a range of ambient tem-perature from August through Octoberof 17 to 35C because of its high altitude(4265 feet above sea level).

Control Groups

Infants randomized to the control groupwere delivered and immediately set ontheir mothers abdomen, then driedwith blankets and stimulated on themothers abdomen while the cord wascut and placenta delivered. If furtherresuscitation was required, a smallnursery in the labor and delivery unitwith radiant warmer and other sup-plies was available. If the infant wasdelivered by cesarean, the infant wasinitially dried and stimulated undera radiant warmer in the operatingroom and then transferred to thenursery in the labor and delivery unit.Resuscitation practices followed theWHO Essential Newborn Care andHelping Babies Breathe training courseprotocols. Infants were transferred tothe nursery, where they were weighed,wrapped (with blankets provided bythe family, usually a terry cloth toweland large eece blanket), covered witha hat, and placed either under a radiantwarmer or in an open crib, depending onavailability. An initial axillary temperaturewas obtained at the time of weighing inthe nursery and a repeat axillary tem-perature was obtained at 1 hour afterbirth. Temperature measurements wereobtained with a digital thermometer.

Per hospital practice, mothers and in-fants were discharged from the hos-pital as early as 6 hours postpartum ifthe infant was not admitted to the NICU.If the infantswereborn in theafternoon,evening, or night, they were dischargedfrom the hospital the next morning.Infantswere admitted to theNICU if theyhad a birth weight ,1400 g, had re-spiratory distress, or had other ab-normal signs requiring observationor treatment. Very low birth weightinfants were routinely discharged fromthe hospital from the NICU when theyattained a weight of.1500 g and wereotherwise medically stable, includingnormal temperatures in an open crib.

Intervention Group

Infants randomized to the interventiongroup received the same care, exceptthey were placed inside a plastic bag(nonmedical low-cost [3 cents per bag]linear low-density polyethylene bagmeasuring 103 83 24 in. and 1.2 mil[mil is a thousandth of an inch] thick)covering the trunk and extremities.Placement in the plastic bag occurredafter brief drying on the mothers ab-domen while the cord was being cutand the infant was handed to the pe-diatrician or assistant and no laterthan 10 minutes after birth. The infantsremained in the plastic bag for at least1 hour after birth, at which time theaxillary temperature was measured.The bag was removed at 1 hour of age ifthe infants temperature was in thenormal range (36.537.5C) or higher.Infants with a temperature below thenormal range remained in the plasticbag until a normal temperature wasobtained.

All study data were collected by 2 of theauthors (A.L. and J.B.W.) and 2 researchassistants trained by those authors.Temperature measurements were alltaken with the same 3 digital ther-mometers. Hard copies of the study datawere controlled by the investigators and

kept in lockedofcesandkept passwordprotected when transferred to digitalles.

Outcomes

The primary outcome was normother-mia at 1 hour. Temperatures wereclassied per WHO guidelines. Normo-thermia was dened per WHO guide-lines as an axillary temperature of 36.5to 37.5C (97.799.5F). The tempera-ture was obtained with a digital ther-mometer placed under the arm of theinfant. Hypothermia was dened as atemperature ,36.5C (97.7F). Hyper-thermia was dened as a temperature.38.0C (100.4F). The temperaturewas obtained with a digital thermom-eter placed in the axilla. Prespeciedsecondary outcomes on patients ad-mitted to the NICU included hypoten-sion, hypoglycemia, seizures during therst 24 hours after birth, respiratorydistress syndrome, bronchopulmonarydysplasia, pneumothorax, sepsis, majorbrain injury (dened as intraventricularhemorrhage Grade 3 or 4 or periven-tricular leukomalacia), necrotizing en-terocolitis, bowel perforation, pulmonaryhemorrhage, and death before dis-charge.

Statistical Analysis

The sample size was estimated basedon historical data from the study centershowing a baseline hypothermia rate of60% in this birth weight range.1,8,30 Wehypothesized a 30% absolute risk re-duction (50% relative reduction) ofhypothermia with the use of the plasticbag. With a preset condence level of95%, power of 80%, and using a conti-nuity correction method, a sample sizeof 50 infants per group was deter-mined to be sufcient to detect a dif-ference between groups.

Descriptive statistics were used tocomparebaselinecharacteristicsof thestudy groups. Continuous variableswere compared with Students t test.

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PEDIATRICS Volume 132, Number 1, July 2013 3

Proportions were compared usingMantel-Haenszel x2/Fishers exact sta-tistics. For risk analysis of the primaryoutcome, risk ratio and condenceintervals for this point estimate werecalculated using contingency tables. Alldata were analyzed with SPSS 17.0 forWindows (IBM SPSS Statistics, IBM Cor-poration, Chicago, IL). All statistical testswere 2-tailed, and P values ,.05 wereconsidered statistically signicant.

RESULTS

Study Participants

A total of 104 infants were randomized(Fig 1). All but 2 infants were randomized

at birth; 2 were randomized within the10-minute limit. All infants had primaryoutcome data. The baseline character-istics of infants randomized to the in-tervention and control groups weresimilar (Table 1). Of all the infants inthe trial, 86 (83%) had a temperature,36.5oC at 10 minutes after birth. Teninfants in the intervention group were,32 weeks gestation (20%) and 14infants in the control group (29%) were,32 weeks gestation.

Primary Outcome

Of the 49 infants in the intervention(plastic bag) group, 29 (59%) compared

with 18 (33%) of 55 infants in the controlgroup had a temperature in the normalrange at 1 hour after birth (relative risk1.81 with 95% condence interval 1.162.81, P = .007). The mean temperatureat 1 hour for infants in the interventiongroup was 36.56 0.5oC compared with36.1 6 0.6oC in control infants (P ,.001). The risk of hypothermia had anabsolute risk reduction of 26% whena plastic bag was used (numberneeded to treat = 4). Temperature at 1hour was correlated with birth weight,with hypothermia being more commonin the smallest infants (Fig 2). The du-ration of use of the plastic bag in hy-pothermic infants ranged from 80 to120 minutes. None of the infants in ei-ther group had hyperthermia. None ofthe infants developed skin side effectsattributable to the plastic bags.

Secondary Outcomes

Most infants were discharged from thehospital with their mothers in ,24hours. Twenty-three of the 104 infants(14 in the intervention group and 9 inthe control group, P = .13) were ad-mitted to the NICU unrelated to the trialinterventions. Among infants admittedto the NICU, no signicant differenceswere found in mean temperature after24 hours of admission, length of hos-pital stay, or death (7 [14%] of 49 in theintervention group versus 3 [5%] of 55in the control group, P = .13). Hypo-tension, hypoglycemia, seizures in therst 24 hours after birth, broncho-pulmonary dysplasia, pneumothorax,major brain injury, bowel perforation,or pulmonary hemorrhage were notdocumented in any of the study infantsduring their NICU admission.

DISCUSSION

This trial shows that placement of thetrunk and extremities of preterm/lowbirth weight infants in a plastic bagat birth or shortly after birth decreasedhypothermia at 1 hour after birth

FIGURE 1Consort diagram.

TABLE 1 Baseline Characteristics

Intervention Group (n = 49) Control Group (n = 55)

Mean birth weight, kg (SD) 2.20 (0.56) 2.11 (0.52)Median gestational age, wk (IQR) 34 (3236) 34 (3136)Gestational age ,32 wk (%) 10 (20) 14 (29)Male gender, n (%) 27 (55.1) 28 (50.9)Vaginal delivery, n (%) 42 (85.7) 51 (92.7)NICU admission, n (%) 14 (28.5) 9 (16.4)Hypothermia at 10 min, n (%) 41 (83.7) 45 (81.8)

IQR, interquartile range.

4 LEADFORD et al

without increasing the risk of hyper-thermia. More than 80% of all theinfants in the study were hypothermicat 10 minutes after birth, when the rsttemperature was taken, documentingthe high prevalence of this problem,even though most of the infants weremore mature or had a higher birthweight than infants for whom plasticbags or wrappings are recommendedbased on trials in developed countries(,29 weeks gestation). Although a re-duction in hypothermia was observed,this resulted from a relatively smalldifference in the actual mean temper-atures (36.1 vs 36.5C).

A limitation of the trial is the shortduration of the intervention. The dura-tion of the intervention was selected toprevent hyperthermia, as well as otherunlikely hazards of placement insidea plastic bag, such as skin damage orsuffocation. Another limitation to thisstudy is the inaccuracy of pregnancydating, which is common in low-resource countries and may explainthe high proportion of infants.2500 gbirth weight. We cannot exclude thepossibility that term infants were en-rolled. The trial was not powered todetect a difference between the groups

with regard to the secondary outcomes.The birth weight and gestational ageentry criteria allowed us to enroll infantswith a low prevalence of these outcomesand therefore we have to conclude thatthese data do not provide evidence oftreatment effect on these clinical out-comes. These outcomes were used assafety measures. The decision to admitan infant to the NICU was made shortlyafter birth, largely related to the birthweight or respiratory status. Thus, theadmission rate is unlikely to be de-pendent on the trial intervention.

Another limitation is the lack of controlof the environmental temperature inthe delivery rooms and resuscitationareas. The hospital did not have centralair-conditioning or heating, and strictcontrol of theambient temperaturewasnot possible. This could affect theinfants temperatures31 and the studycould not control for it. However, eventhough ambient temperature can af-fect the temperature of the newborn,the plastic bags were able to reducehypothermia without causing hyper-thermia in this stressful environment.Infants were dried at birth per WHOguidelines, but this may not be neces-sary when plastic bags are used.2024

Just as we found in the current trial,hyperthermia has not been reported inprevious randomized controlled trialsof plastic wrappings.20,21,24 Further-more, there is in vitro evidence thatindicates that plastic bags should notcause hyperthermia.32

We studied plastic bags against nor-mal thermoregulation practices, notagainst skin-to-skin contact with themother, specically because pretermand low birth weight infants frequentlyhave to be separated from their moth-ers soon after birth. Data have beenpublished regarding the thermoreg-ulation benets of skin-to-skin con-tact with the mother.33,34 The WHOEssential Newborn Care curriculumincludes skin-to-skin contact with themother in the rst few hours afterbirth for thermoregulation and earlybreast feeding.35 However, in a largestudy, hypothermia occurred in 43%and 49% of normal birth weight andlow birth weight infants despite a 75%rate of skin-to-skin contact with themother during the rst 24 hours afterbirth.36

The use of plastic bags or polyethylenewrapping in very low birth weightinfants in the delivery room is a com-mon practice in the developed world.Previous studies have shown thatplastic bags or wrappings reduce hy-pothermia in infants at ,29 weeksgestation.21,24 Although infants down to26 weeks and 1000 g were included inour trial, they constituted a small pro-portion of the enrolled infants. Largerinfants also have trouble maintaininga normal temperature in the earlyminutes to hours after birth, and thecurrent trial demonstrates that plasticbags may also reduce hypothermia inthese infants. The relatively high prev-alence of hypothermia, even in thelarger infants enrolled in the currenttrial suggests that these infants maybenet from placement inside a plasticbag shortly after birth.

FIGURE 2Temperature 1 hour after birth in infants randomized to a plastic bag or control group plotted by birthweight. The dotted lines are the limits of normothermia. More infants randomized to a plastic bagcompared with control infants had normal temperatures. The effect happened across the birth weightstrata. Hyperthermia (.38C) was not seen.

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There are limited data from high-levelevidence studies on thermoregulationin preterm/low birth weight infants indeveloping countries. A randomizedcontrolled trial, which enrolled 110infants of 24 to 34 weeks gestation ina NICU in Malaysia, showed that al-though plastic wrapping increasedtemperatures, 78% of the infants in thetreatment group became hypothermiceven though the incidence of hypo-thermia was slightly reduced.37

Hypothermia has long been linked to anincreased risk of mortality.1,3,4,8,9,30 It isan accepted and logical standard ofcare in NICUs and labor wards aroundthe world to provide thermal protection

to newborns, and admission tempera-ture can be used to gauge the successof resuscitation. Larger randomizedcontrolled studies are needed to de-termine if improving the temperatureimmediately after birth improves anyother long-term outcomes.

This randomized controlled trial sup-ports the hypothesis that placement ofpreterm and low birth weight infantsinside a plastic bag soon after birthreduces hypothermia and increasesnormothermia without causing hyper-thermia or other complications. Be-cause of the high rate of hypothermia inthepopulationstudied, these resultsmaybe most generalizable to populations

with high rates of hypothermia. Place-ment of infants at birth in a plastic bag isa low-costandpromising intervention forinfants born in limited-resource settingswhere there is limited availability of ra-diant warmers and incubators.

ACKNOWLEDGMENTSWe thankMonica Collins RN, BSN, MaEd,and Becky Brazeel, CPS, CAP, from theUniversity of Alabama at Birmingham;Clement C. Mwamba and Lydia Mapalafrom the University of Zambia; FrancoMudekwa from the Lusaka Nursing In-stitute; and all the nurse midwives atUniversity Teaching Hospital in Lusakafor their help in completing this project.

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