Randomized Trial of Plastic Bags to Prevent Term

DOI: 10.1542/peds.2013-0172; originally published online August 26, 2013; 2013;132;e656Pediatrics

Namasivayam Ambalavanan and Waldemar A. CarloAlicia Leadford, Albert Manasyan, Elwyn Chomba, Manimaran Ramani,

Theodore C. Belsches, Alyssa E. Tilly, Tonya R. Miller, Rohan H. Kambeyanda,Resource-Poor Setting

Randomized Trial of Plastic Bags to Prevent Term Neonatal Hypothermia in a

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Randomized Trial of Plastic Bags to Prevent TermNeonatal Hypothermia in a Resource-Poor Setting

WHATS KNOWN ON THIS SUBJECT: Term neonates in resource-poor settings frequently develop hypothermia. Plastic bags orwraps are a low-cost intervention for the prevention ofhypothermia in preterm and low birth weight infants that mayalso be effective in term infants.

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

abstractOBJECTIVES: Term infants in resource-poor settings frequently develophypothermia during the rst hours after birth. Plastic bags or wrapsare a low-cost intervention for the prevention of hypothermia inpreterm and low birth weight infants that may also be effective interm infants. Our objective was to test the hypothesis thatplacement of term neonates in plastic bags at birth reduceshypothermia at 1 hour after birth in a resource-poor hospital.

METHODS: This parallel-group randomized controlled trial was con-ducted at University Teaching Hospital, the tertiary referral centerin Zambia. Inborn neonates with both a gestational age $37 weeksand a birth weight $2500 g were randomized 1:1 to either a standardthermoregulation protocol or to a standard thermoregulation protocolwith placement of the torso and lower extremities inside a plastic bagwithin 10 minutes after birth. The primary outcome was hypothermia(,36.5C axillary temperature) at 1 hour after birth.

RESULTS: Neonates randomized to plastic bag (n = 135) or to standardthermoregulation care (n = 136) had similar baseline characteristics(birth weight, gestational age, gender, and baseline temperature).Neonates in the plastic bag group had a lower rate of hypothermia(60% vs 73%, risk ratio 0.76, condence interval 0.600.96, P = .026)and a higher axillary temperature (36.4 6 0.5C vs 36.2 6 0.7C, P ,.001) at 1 hour after birth compared with infants receiving standardcare.

CONCLUSIONS: Placement in a plastic bag at birth reduced the inci-dence of hypothermia at 1 hour after birth in term neonates born ina resource-poor setting, but most neonates remained hypothermic.Pediatrics 2013;132:e656e661

AUTHORS: Theodore C. Belsches, MD,a Alyssa E. Tilly, MD,a

Tonya R. Miller, MD,a Rohan H. Kambeyanda, MD,a AliciaLeadford, MD,a Albert Manasyan, MD,a,b Elwyn Chomba,MD,a,b,c Manimaran Ramani, MD,a NamasivayamAmbalavanan, MD,a and Waldemar A. Carlo, MDa,b

aDepartment of Pediatrics, University of Alabama at Birmingham,Birmingham, Alabama; bCentre for Infectious Disease Researchin Zambia, Lusaka, Zambia; and cDepartment of Pediatrics,University Teaching Hospital, Lusaka, Zambia

KEY WORDSinfant, term, infant, newborn, infant, hypothermia/prevention andcontrol, plastic bag, bedding and linens, body temperature,regulation, polyethylenes, delivery, obstetrics

ABBREVIATIONSCIcondence intervalRRrisk ratioWHOWorld Health Organization

Mr Belsches conceptualized and designed the study, coordinatedand supervised data collection, and carried out the initialanalyses; Ms Tilly assisted in study design, coordinated andsupervised data collection, and drafted the initial manuscript;Ms Miller assisted in study design and data collection; MrKambeyanda conceptualized and designed the study andassisted in data collection; Drs Leadford and Carloconceptualized and designed the study; Drs Manasyan andChomba assisted in study design; Drs Ramani and Ambalavananassisted in study design and performed the statistical analyses;and all authors reviewed and revised the manuscript, andapproved the nal manuscript as submitted.

This trial has been registered at www.clinicaltrials.gov(identier NCT 01604460).

www.pediatrics.org/cgi/doi/10.1542/peds.2013-0172

doi:10.1542/peds.2013-0172

Accepted for publication Jun 24, 2013

Address correspondence to Waldemar A. Carlo, MD, University ofAlabama at Birmingham, 1700 6th Ave S, 176F Suite 9380,Birmingham, AL 35249-7335. E-mail: [email protected]

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 in part by grants from the Eunice KennedyShriver National Institute of Child Health and HumanDevelopment Global Network for Womens and Childrens HealthResearch (U01HD043464), the Perinatal Health and HumanDevelopment Research Program of the University of Alabama atBirmingham, and the Childrens of Alabama Centennial ScholarFund. Funded by the National Institutes of Health (NIH).

POTENTIAL CONFLICT OF INTEREST: Dr Carlo is on the Board ofDirectors of Mednax, Inc; the other authors have indicated theyhave no potential conicts of interest to disclose.

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Approximately 3 million neonates dieannually worldwide.1 Compared withthe developed world, neonatal mortal-ity in the developing world is 6 timeshigher.2 Hypothermia, in particular, isassociated with increased neonatalmortality,3,4 and each 1C decrease inaxillary temperature is associated witha 75% increase in neonatal mortality.5

Hypothermia in newborns occurs in allclimates, and the highest risk is withinthe rst minutes to hours after birth asthe newborn adjusts to the extrauter-ine environment.5,6

Standard thermoregulation World HealthOrganization (WHO) guidelines recom-mend comprehensive measures toprevent hypothermia, including warmdelivery rooms, immediate drying, skin-to-skin contact, early breast feeding,postponed bathing and weighing, appro-priate clothing and bedding, and warmtransportation and resuscitation.7 How-ever, hypothermia still occurs in spiteof these techniques, as reported in alarge study in rural India in which therewas a 49% rate of hypothermia in lowbirth weight infants and a 43% rate innormal birth weight infants.8

In randomized controlled trials in de-veloped countries, placement of verylowbirthweightandverypreterminfantsin occlusive polyethylene plastic bags orwraps decreased hypothermia.912 Sys-tematic reviews of randomized con-trolled trials and historical controlledtrials found that occlusive skin wrappingat delivery increases NICU admissiontemperature and reduces hypothermiain preterm infants.13,14 Plastic bags orwraps aid in thermal regulation by pro-tecting infants from radiant, evaporative,and convective heat loss.15,16 Random-ized trials of plastic bag use during therst hour after birth in larger preterminfants showed decreased rates of hy-pothermia.1719 It is possible that theaddition of the plastic bag to standardWHO thermoregulation care may be aneffective intervention to decrease rates

of hypothermia in term neonates. Thecurrent trial sought to determine ifplacing term infants in polyethyleneplastic bags at birth reduces hypother-mia 1 hour after birth.

METHODS

Study Design

This randomized controlled trial wasconducted at University Teaching Hos-pital, the tertiary referral center inLusaka, Zambia. The trial was approvedby the institutional review boards ofUniversity Teaching Hospital in Lusaka,Zambia, and the University of Alabamaat Birmingham (clinicaltrials.gov iden-tier NCT01604460). Infants born at thehospital with both a gestational age of$37 weeks and a birth weight$2500 gwere eligible for inclusion in the trial.Gestational age was determined bybest obstetrical estimate, predominantlylast menstrual period. Exclusion criteriaincluded planned admission to the NICU,abdominal wall defect, myelomeningo-cele, major congenital anomaly, or blis-tering skin disorder. After arrival in thelabor and delivery unit, mothers of po-tentially eligible infants were identied,and consent for the study was obtainedeither before delivery or within 10minutes after birth by 4 of the authors(T.C.B., A.E.T., T.R.M., R.H.K.). Enrollmentof participants took place from Junethrough July 2012 and occurred duringboth day and night shifts.

After parental consent was obtained,infants were randomized by 4 of theauthors (T.C.B., A.E.T., T.R.M., R.H.K.)within 10 minutes of birth using a 1:1allocation parallel design to eithera standard thermoregulation protocolor to a standard thermoregulation pro-tocol with placement inside a plastic bagwithout drying. Sealed sequentiallynumbered envelopes with a computer-generated random allocation sequencewere used for randomization tomaintainallocation concealment. Multiple birthswere randomized individually. The

10-minute window for consent andenrollment allowed the inclusion ofinfants whose mothers delivered pre-cipitously and infantswhenmore than 1birth occurred at once.

Control Group

Infants randomized to the control groupreceived standard hospital care basedon WHO thermoregulation of the new-born protocol.7 This included warmdelivery room efforts, immediate dry-ing, skin-to-skin contact, early and ex-clusive breast feeding, postponedbathing, bundling, and incubator orradiant warmer if the infants conditiondictated. Kangaroo care with skin-to-skin, chest-to-chest contact occurredwhile the cord was clamped and theinfant was dried. Infants were thentransferred to the nursery at approxi-mately 10 minutes after birth accord-ing to local practice. In the nursery,infants were weighed, and an initialaxillary temperature was obtained. Theinfants were swaddled in blanketsprovided by the mother (usually a terrycloth and a eece blanket), the headwas covered with a hat, and the infantswere placed either in an open crib orunder a radiant warmer as necessaryand available. On admission to thenursery, infants found to have an initialaxillary temperature ,36.0C wereplaced under a radiant warmer for therst hour after birth, and those withtemperatures $36.0C were placed inan open crib. A repeat axillary tem-perature was taken at 1 hour afterbirth. Using a digital air-temperaturethermometer, the room temperaturewas recorded at the time of each axil-lary temperature measurement. Effortsto maintain the air temperature in-cluded a space heater in each deliveryroom and one in the nursery.

Intervention Group

The intervention group infants wereprovided the same care as control

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infants except that their torso andlowerextremitieswereplaced inaclearpolyethylene plastic bag (inexpensive[3 cents/bag] 10 3 8 3 24-in, 1.2-mil[thousandth of an inch]-thick non-medical polyethylene bag) within 10minutes after birth. The plastic bagwas placed against the skin and wassecured under the neonates arms andaround the chest by tightly swaddlingthe neonate with a terry cloth towel orthin blanket provided by the infantsmother. Care was exercised to preventthe bag from covering the mouth ornose. The intervention group infantsremained in the plastic bag for the rsthour after birth. The plastic bags werechanged when soiled. Kangaroo carewith skin-to-skin, chest-to-chest con-tact with the mother occurred with theinfant remaining in the bag the rst fewmoments after birth before transfer tothe nursery.

Outcomes

The primary outcomemeasure was thepresence of hypothermia (,36.5Caxillary temperature) at 1 hour afterbirth with hypothermia divided into theWHO categories of mild (36.036.4C),moderate (32.035.9C), and severe(,32.0C) (WHO thermoregulation).The temperature was obtained usinga single measurement in 1 axilla witha digital thermometer. Secondary out-come measures included hyperther-mia (.38C at 1 hour after birth) anddeath (before discharge).

Statistical Analysis

The sample size was calculated basedon a predicted 15% prevalence of hy-pothermia in full-term infants at 1 hourafter birth, assuming a lower preva-lence of hypothermia than that found inpreterm infants during a previous trialat the same hospital.18,20 A sample sizeof 276 was necessary to detect a 10%absolute risk reduction (67% relativereduction), with a 95% condence level,

80% power, and continuity correctionmethod.

The baseline characteristics of eachgroup were compared using de-scriptive statistics. The Students t testand x2 were used to compare contin-uous and categorical variables, re-spectively. Fishers exact test was usedfor events with low prevalences. Riskratio (RR) and condence intervals(CIs) were determined using contin-gency tables for risk analysis of theprimary outcome. Correlations werecalculated using simple linear regres-sions. All analyses were prespeciedexcept for the exploratory subgroupanalysis of neonates normothermic at15 minutes after birth. P values ,.05were signicant, and all tests were2-tailed. SPSS 17.0 for Windows(IBM SPSS Statistics, IBM Corporation,Chicago, IL) was used to analyze alldata by modied intention-to-treat ex-cluding neonates admitted to the NICUduring the rst hour after birth fromthe primary outcome analysis.

RESULTS

During the cold season from June 20 toJuly 12, 2012, 136 neonates were en-rolled in the intervention group and 139in the control group (Fig 1). Data from 3infants (2 in the control and 1 in the

intervention group) born after preg-nancies initially thought to be term butwith an estimated gestational age,37weeks were included in the analyses.Four enrolled neonates (3 from thecontrol and 1 from the interventiongroup) were admitted to the NICU be-fore 1 hour after birth because ofrespiratory distress (n = 3) and hypo-glycemia (n = 1) and were excludedfrom the analyses. Baseline charac-teristics of the control and interventiongroups were similar except that theroom temperature within 15minutes ofbirth of the control group was higher(P = .023, Table 1).

Neonates placed in a plastic bag hadsignicantly less hypothermia at 1 hourafter birth than infants receivingstandard care (60% vs 73%, RR 0.76,condence interval 0.600.96, P = .026,Table 2). The intervention group alsohad higher average axillary temper-atures at 1 hour after birth, largerincreases in axillary temperature overthe rst hour after birth, and lowerrates of moderate hypothermia (allP, .001, Table 2). None of the infants inthe trial developed severe hypother-mia. The room temperature at 1 hourafter birth did not differ between theintervention and control groups. Therewas a positive correlation betweenbirth weight and temperature at 1 hour

FIGURE 1Flow of participants through enrollment, randomization, and analysis of the study.


after birth among infants in the controlgroup (R = 0.351, P , .001) but not inthe intervention group infants (R =0.109, P = .206). There was no corre-lation between the room tempera-tures and axillary temperatures at 15minutes after birth or at 1 hour afterbirth.

A subgroup analysis of infants nor-mothermic ($36.5C) at 15 minutesafter birth showed similar baselinecharacteristics (Table 3). There wasno difference in the overall de-velopment of hypothermia at 1 hourafter birth. The intervention group had

a lower rate of moderate hypothermia(2% vs 18%, RR 0.17, condence in-terval 0.031.14, P = .007, Table 3) andsmaller decreases in axillary temper-ature over the rst hour after birth(P = .021, Table 3).

One infant in the intervention groupdeveloped hyperthermia (38.1C) butbecame normothermic soon after re-moval from the radiant warmer. Therewere no deaths or other adverseevents before discharge. The plasticbag was well accepted by the labor anddelivery staff and did not interfere withneonatal resuscitation. Kangaroo care

was done usually for less than 10minutes as mothers were moved fromthe delivery beds to the recovery areabecause of the high demand for de-livery beds. There were only 4 radiantwarmers, which were insufcient attimes, and windows were often open inthe nursery and delivery rooms. Half ofthe enrollments occurred at nightwhen the outside air temperature wasmuch cooler. Despite this, includingmeasurements in both the nursery anddelivery rooms, the infants were pre-dominantly in rooms within the WHOsrecommended room temperature range(mean 27.4C, median 27.3C, range22.032.9C).7

DISCUSSION

In the current trial, placing neonates ina plastic bag during the rst hour afterbirth reduced hypothermia and in-creased the axillary temperature whencompared with standard thermoregu-latory care alone. As shown in trials ofpreterm very low birth weight and lowbirth weight infants,10,17,18 there wasa positive correlation between birthweight and temperature at 1 hour afterbirth, but the correlation was weakerin the intervention group, suggestingthat the plastic bag has a greater effecton infants with a lower birth weight.Even neonates who were normother-mic at 15 minutes after birth benetedfrom the plastic bags by developinga lower rate of moderate hypothermiaand smaller decreases in axillarytemperature over the rst hour afterbirth. These data support the plasticbag as an inexpensive, effective, short-term intervention to reduce the ratesof hypothermia in term infants thatcould be introduced in resource-poorsettings because of its effectivenessand affordability.

Ideal thermoregulatory care was lim-ited by various limitations in the hos-pital facilities and care that likelycontributed to the high rates of overall

TABLE 1 Baseline Characteristics of the Intervention and Control Groups

Intervention, n = 135 Control, n = 136

Birth weight, kg, mean 6 SD. 3.18 6 0.39 3.13 6 0.43#2.50, n (%)a 3 (2) 11 (8)2.513.00, n (%) 48 (36) 45 (33)3.013.50, n (%) 64 (47) 59 (43)3.514.00, n (%) 15 (11) 18 (13).4.00, n (%) 5 (4) 3 (2)Gestational age, wk, mean 6 SDb 39.0 6 1.4 39.0 6 1.9,37, n (%) 1 (1) 2 (1)3738, n (%) 54 (40) 54 (40)3940, n (%) 65 (48) 56 (41)4142, n (%) 13 (10) 19 (14).42, n (%) 2 (1) 4 (3)Male gender, n (%) 71 (53) 68 (50)NICU admission, n (%) 0 (0) 1 (1)Room temperature at 15 min, C, mean 6 SDb,c 27.4 6 1.5 27.8 6 1.5Body temperature at 15 min, C, mean 6 SDb 36.2 6 0.7 36.3 6 0.7Hypothermia (,36.5C) at 15 min, n (%)b 84 (63) 81 (60)Body temperature ,36C at 15 min, n (%)b 44 (33) 40 (30)a P = .051.b May reect as many as 5 missing values.c P = .023.

TABLE 2 Outcomes at 1 Hour After Birth

Intervention, n = 135 Control, n = 136 P RR (95% CI)

Hypothermia (,36.5C), n (%) 81 (60) 99 (73) .026a 0.824 (0.690.99)Mild hypothermia

(36.036.4C), n (%)55 (41) 48 (35) .357a 1.15 (0.841.60)

Moderate hypothermia(32.035.9C), n (%)

26 (19) 51 (38) ,.001a 0.51 (0.330.79)

Severe hypothermia(,32.0C), n (%)

0 0

Temperature at 1 h, C,mean 6 SD.

36.4 6 0.5 36.2 6 0.7 ,.001b

Change in temperature from15 min to 1 h, C, mean 6 SDc

+0.2 6 0.7 20.1 6 0.6 ,.001b

CI, condence interval; NA, .a x2.b Students t test.c Reects 1 missing value in each group.

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hypothermiaat 1hourand thedecreasein temperature at 1 hour in the infantswho were initially normothermic. Thedelivery roomandnurserywereusuallywithin the recommended minimaltemperature range of 25 to 28C,7 butother standard thermoregulatorypractices were difcult to follow. Thelimited use of kangaroo care, in-sufcient radiant warmers, and aircurrents created by the open windowslikely contributed to the high rate ofhypothermia overall and drop in tem-perature of initially normothermicinfants. Despite these difculties, useof a plastic bag signicantly decreasedhypothermia, suggesting its applica-bility and effectiveness in less thanideal conditions. In resource-poor set-tings there is likely to be some delaybefore an infant is placed in a plasticbag, and the 10-minute window forplacement in a plastic bag included inthis trial shows that even with a delay,the plastic bag is effective at reducinghypothermia.

The average birth weight of the in-tervention group was 50 g heavierthan that of the control group, po-tentially explaining a portion of thelower rate of hypothermia at 1 hourafter birth seen in the interventiongroup. But because a categoricalanalysis of the birth weights shows nodifference and there is no differencebetween the axillary temperatures at15 minutes after birth, we believe thatthe 2 groups are comparable and theplastic bag is the primary reason forthe lower rate of hypothermia seen inthe intervention group at 1 hour afterbirth.

All infants are at increased risk forhypothermiabecause of their highbodysurface areato-volume ratio. Althoughthe incidence of hypothermia is lowerin term infants than in preterm in-fants, term infants also experiencehypothermia in settings where cli-mate control is difcult.8,18,21,22 A studyin Nepal found 46% of term infants

(n = 353) to be hypothermic (,36C) 24hours after birth.21 Similarly, a study inUganda showed that 79% of the 300newborns (64% were .2500 g) be-came hypothermic (,36.5C) 90minutes after birth.22 The current trialshowed a similar rate of hypothermia(73%) in infants in the control groupreceiving standard thermoregulatorycare. Thus, term infants are at high riskfor hypothermia in these settings, andthe current trial indicates that terminfants benet from placement inplastic bags as also shown in preterminfants.

Anearlier trialat thestudysite involvingpreterm infants had a lower rate ofhypothermia in the control group thanthat seen in the current study (59% to73%).18 Besides the current study oc-curring during a colder month andenrolling more infants at night, thedifference in the rate of hypothermiamay be because of the labor and de-livery staff being more vigilant to pre-vent hypothermia in preterm infants.Most of the infants in the current trailhad mild hypothermia; however, a pre-vious report from this study sitereported moderate rates of hypother-mia of 44% in 0- to 7-day neonates ad-mitted to the NICU.20

The plastic bag intervention is easy toimplement, as it is inexpensive (3cents/bag and 1 bag/infant) andreadily accepted by the labor and de-livery staff after demonstrating thatterm infants frequently develop hy-pothermia. Folding the bag un-derneath the infants axillae, leavingthe arms outside of the bag, andtightly swaddling the infant reduce thepossibility of suffocation. Mild hyper-thermia occurred only once, but maybe a risk.

In summary, in resource-poor settingswhere the availability of radiantwarmers and incubators may be lim-ited, plastic bags may be useful tools inreducing the rates of hypothermia.

TABLE 3 Normothermic (.36.5C) Neonates at 15 Minutes After Birth Subgroup Analysis

Intervention, n = 51 Control, n = 55 P RR (95% CI)

Baseline characteristicsBirth weight, kg, mean 6 SD 3.18 6 0.36 3.17 6 0.36 Gestational age, wk, mean 6 SDa 39.0 6 1.5 39.3 6 1.9 Male gender, n (%) 24 (47) 23 (42) NICU admission, n (%) 0 0 Room temperature at 15 min,

C, mean 6 SDa27.4 6 1.4 27.9 6 1.5

Body temperature at 15 min,C, mean 6 SDa

36.9 6 0.3 36.9 6 0.4

Outcomes at 1 h after birthb

Hypothermia (,36.5C), n (%) 17 (33) 25 (45) .205c 0.73 (0.431.23)Mild hypothermia

(36.036.4C), n (%)16 (31) 15 (27) .644c 1.15 (0.602.22)

Moderate hypothermia(32.035.9C), n (%)

1 (2) 10 (18) .008d 0.11 (0.010.76)

Severe hypothermia(,32.0C), n (%)

0 0 NA NA

Body temperature at 1 h,C, mean 6 SD

36.7 6 0.5 36.6 6 0.6 .106e

Avg. increase in temperaturefrom 15 min to 1 h,C, mean 6 SDa

20.2 6 0.4 20.4 6 0.5 .021e

CI, condence interval; NA, .a May reect as many as 1 missing value.b There was no observed difference in room temperature at 1 h after birth.c x2.d Fishers exact test.e Students t test.


Further trials are needed to determinewhether this low-cost interventionreduces morbidity and mortality as-sociated with hypothermia.

ACKNOWLEDGMENTSWe thank Monica Collins, RN, Med, andBecky Brazeel, CPS, CAP, from the Uni-versity of Alabama at Birmingham,

and the nurses and midwives fromthe University Teaching Hospitalin Lusaka for their help with thisproject.

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DOI: 10.1542/peds.2013-0172; originally published online August 26, 2013; 2013;132;e656Pediatrics

Namasivayam Ambalavanan and Waldemar A. CarloAlicia Leadford, Albert Manasyan, Elwyn Chomba, Manimaran Ramani,

Theodore C. Belsches, Alyssa E. Tilly, Tonya R. Miller, Rohan H. Kambeyanda,Resource-Poor Setting

Randomized Trial of Plastic Bags to Prevent Term Neonatal Hypothermia in a

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