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a temperature in the normal range as compared with infants in the FINANCIAL DISCLOSURE: The authors have indicated they have
no financial relationships relevant to this article to disclose.
standard thermoregulation care group (n = 55; 59.2% vs 32.7%; relative
FUNDING: Supported by grants from the Eunice Kennedy Shriver
risk 1.81; 95% confidence interval 1.16–2.81; P = .007). The temperature
National Institute of Child Health and Human Development Global
at 1 hour after birth in the infants randomized to plastic bag was 36.5 Network for Women’s and Children’s Health Research
6 0.5°C compared with 36.1 6 0.6°C in standard care infants (P , (HD043464), Perinatal Health and Human Development Research
.001). Hyperthermia (.38.0°C) did not occur in any infant. Program of the University of Alabama at Birmingham, and
Children’s of Alabama Centennial Scholar Fund. Funded by the
CONCLUSIONS: Placement of preterm/low birth weight infants inside National Institutes of Health (NIH).
a plastic bag at birth compared with standard thermoregulation care
reduced hypothermia without resulting in hyperthermia, and is a low-
cost, low-technology tool for resource-limited settings. Pediatrics
2013;132:e128–e134
e128 LEADFORD et al
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Annually, about 3 million infants die metabolic heat production.17,25,26 McCall Lusaka, Zambia (Clinicaltrials.gov iden-
during the neonatal period worldwide.1 et al,27 in a Cochrane review (including 3 tifier NCT01403623).
More than 80% of these neonatal studies of polyethylene wrappings used Infants born at the hospital were eli-
deaths can be attributed to infection, within 10 minutes of birth in infants gible for inclusion if they were between
birth asphyxia, complications of pre- ,32 weeks’ gestation), concluded that 26 weeks 0 days and 36 weeks 6 days of
mature delivery, including hypothermia, the use of plastic wraps or bags gestation at birth according to the best
and congenital anomalies.2 Hypother- decreases hypothermia soon after birth obstetrical estimate (using last men-
mia has long been recognized as a se- and recommended future research to strual period, fundal height, and ul-
rious risk to newborns, especially determine the feasibility of their use in trasound as assessed by the obstetric
premature and low birth weight poorer countries where cost is a con- team) or if their birth weight was be-
infants,3–6 and is a problem in both the cern. The Neonatal Resuscitation Pro- tween 1000 and 2500 g. Infants were
developed7 and the developing world.1,8–10 gram recommends the use of a plastic excluded if they had an abdominal wall
Neonatal hypothermia has been asso- bag as a means to prevent hypothermia defect, myelomeningocele, other major
ciated with increased risk of infection, in infants born at ,29 weeks’ gestation.28 congenital anomaly, or obvious skin
coagulation defects, acidosis, delayed The International Liaison Committee on disorders. Mothers of eligible infants
fetal-to-newborn circulatory adjustment, Resuscitation consensus statement rec- were identified on admission to the
hyaline membrane disease, brain hem- ommends the use of a plastic bag in labor and delivery unit and approached
orrhage, increased oxygen consumption, addition to standard techniques in the for consent before delivery or within 10
and increased mortality.3,5,11–13 Infants delivery room for very low birth weight minutes after delivery if previous con-
are most at risk for hypothermia in the infants.29 sent was not possible. Written informed
first few minutes to hours after birth, Plastic bags may be an affordable op- consent from the mother was obtained
when they are first removed from the tion for developing countries. The cur- for each infant. Enrollment occurred
thermally regulated intrauterine envi- rent trial was designed to test the from August through October 2011.
ronment.5,12,14 Hypothermia can occur in hypothesis that use of low-cost plastic Infants were randomized during both
infants of all countries, including tropical (polyethylene) bags starting at birth day and night shifts.
climates.8,9,15,16 reduces hypothermia without causing In a 1:1 allocation and parallel design,
The World Health Organization (WHO) hyperthermia at 1 hour after birth in infants were randomly assigned to 1 of
recommendations to prevent hypo- preterm and low birth weight infants. the 2 treatment groups at birth. Ran-
thermia include a warm delivery room This trial enrolled more mature and
domization occurred at birth or within
larger infants than previously studied
(25°C), immediate drying, and re- the first 10 minutes after birth. Twins
suscitation under radiant warmers, because in resource-limited settings
and higher-order multiples were ran-
skin-to-skin contact with the mother, or these infants are at high risk of hypo-
domized individually. Randomization
an incubator.17 Low-cost technologies thermia.
was blinded and done by using sealed
used to prevent hypothermia in pre- numbered envelopes assigned by a
term and very low birth weight infants METHODS random number generator. Study in-
in the developed world could be ex- Study Design vestigators kept the sealed envelopes
tended to the developing world. In this single-center randomized con- and opened them at the birth of the
Evaporative heat loss is the major cause trolled trial conducted at the tertiary infant. Blinding of the intervention was
of heat loss in newborn infants during University Teaching Hospital in Lusaka, not possible.
the first 30 minutes after birth.18 In- Zambia, a standard thermoregula- The University Teaching Hospital in
sensible water loss and an immature tion care strategy (control group) was Lusaka is a tertiary referral, teaching
skin barrier contribute to the increased compared with a strategy including hospital in the capital of Zambia. There
risk of hypothermia in infants.5,19 Poly- standard thermoregulation care plus are approximately 11 000 to 13 000
ethylene occlusive wrapping or plastic placement of the newborn in a low-cost annual births, almost exclusively from
bags used at birth in the delivery room polyethylene bag (intervention group). high-risk referrals. The ward is staffed
reduce hypothermia in extremely low The study was approved by the in- by midwives, obstetrics-gynecology
and very low birth weight infants.20–24 It stitutional review boards of the Uni- residents, and attending obstetricians.
is thought that plastic bags reduce versity of Alabama at Birmingham, There is ultrasound and cesarean de-
evaporative/convective heat losses, in- Oregon Health & Science University, livery capability. Electronic fetal moni-
sensible water loss, and the need for and University Teaching Hospital in toring during labor is not available.
e130 LEADFORD et al
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Proportions were compared using at birth; 2 were randomized within the with 18 (33%) of 55 infants in the control
Mantel-Haenszel x 2/Fisher’s exact sta- 10-minute limit. All infants had primary group had a temperature in the normal
tistics. For risk analysis of the primary outcome data. The baseline character- range at 1 hour after birth (relative risk
outcome, risk ratio and confidence istics of infants randomized to the in- 1.81 with 95% confidence interval 1.16–
intervals for this point estimate were tervention and control groups were 2.81, P = .007). The mean temperature
calculated using contingency tables. All similar (Table 1). Of all the infants in at 1 hour for infants in the intervention
data were analyzed with SPSS 17.0 for the trial, 86 (83%) had a temperature group was 36.5 6 0.5oC compared with
Windows (IBM SPSS Statistics, IBM Cor- ,36.5oC at 10 minutes after birth. Ten 36.1 6 0.6oC in control infants (P ,
poration, Chicago, IL). All statistical tests infants in the intervention group were .001). The risk of hypothermia had an
were 2-tailed, and P values ,.05 were ,32 weeks’ gestation (20%) and 14 absolute risk reduction of 26% when
considered statistically significant. infants in the control group (29%) were a plastic bag was used (number
,32 weeks’ gestation. needed to treat = 4). Temperature at 1
RESULTS hour was correlated with birth weight,
Study Participants Primary Outcome with hypothermia being more common
in the smallest infants (Fig 2). The du-
A total of 104 infants were randomized Of the 49 infants in the intervention
ration of use of the plastic bag in hy-
(Fig 1). All but 2 infants were randomized (plastic bag) group, 29 (59%) compared
pothermic infants ranged from 80 to
120 minutes. None of the infants in ei-
ther group had hyperthermia. None of
the infants developed skin side effects
attributable to the plastic bags.
Secondary Outcomes
Most infants were discharged from the
hospital with their mothers in ,24
hours. Twenty-three of the 104 infants
(14 in the intervention group and 9 in
the control group, P = .13) were ad-
mitted to the NICU unrelated to the trial
interventions. Among infants admitted
to the NICU, no significant differences
were found in mean temperature after
24 hours of admission, length of hos-
pital stay, or death (7 [14%] of 49 in the
intervention group versus 3 [5%] of 55
in the control group, P = .13). Hypo-
tension, hypoglycemia, seizures in the
first 24 hours after birth, broncho-
pulmonary dysplasia, pneumothorax,
FIGURE 1 major brain injury, bowel perforation,
Consort diagram.
or pulmonary hemorrhage were not
documented in any of the study infants
TABLE 1 Baseline Characteristics during their NICU admission.
Intervention Group (n = 49) Control Group (n = 55)
Mean birth weight, kg (SD) 2.20 (0.56) 2.11 (0.52) DISCUSSION
Median gestational age, wk (IQR) 34 (32–36) 34 (31–36)
Gestational age ,32 wk (%) 10 (20) 14 (29) This trial shows that placement of the
Male gender, n (%) 27 (55.1) 28 (50.9) trunk and extremities of preterm/low
Vaginal delivery, n (%) 42 (85.7) 51 (92.7)
NICU admission, n (%) 14 (28.5) 9 (16.4) birth weight infants in a plastic bag
Hypothermia at 10 min, n (%) 41 (83.7) 45 (81.8) at birth or shortly after birth decreased
IQR, interquartile range. hypothermia at 1 hour after birth
e132 LEADFORD et al
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There are limited data from high-level to newborns, and admission tempera- with high rates of hypothermia. Place-
evidence studies on thermoregulation ture can be used to gauge the success ment of infants at birth in a plastic bag is
in preterm/low birth weight infants in of resuscitation. Larger randomized a low-cost and promising intervention for
developing countries. A randomized controlled studies are needed to de- infants born in limited-resource settings
controlled trial, which enrolled 110 termine if improving the temperature where there is limited availability of ra-
infants of 24 to 34 weeks’ gestation in immediately after birth improves any diant warmers and incubators.
a NICU in Malaysia, showed that al- other long-term outcomes.
though plastic wrapping increased This randomized controlled trial sup- ACKNOWLEDGMENTS
temperatures, 78% of the infants in the ports the hypothesis that placement of We thank Monica Collins RN, BSN, MaEd,
treatment group became hypothermic preterm and low birth weight infants and Becky Brazeel, CPS, CAP, from the
even though the incidence of hypo- inside a plastic bag soon after birth University of Alabama at Birmingham;
thermia was slightly reduced.37 reduces hypothermia and increases Clement C. Mwamba and Lydia Mapala
Hypothermia has long been linked to an normothermia without causing hyper- from the University of Zambia; Franco
increased risk of mortality.1,3,4,8,9,30 It is thermia or other complications. Be- Mudekwa from the Lusaka Nursing In-
an accepted and logical standard of cause of the high rate of hypothermia in stitute; and all the nurse midwives at
care in NICUs and labor wards around the population studied, these results may University Teaching Hospital in Lusaka
the world to provide thermal protection be most generalizable to populations for their help in completing this project.
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e134 LEADFORD et al
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Plastic Bags for Prevention of Hypothermia in Preterm and Low Birth Weight
Infants
Alicia E. Leadford, Jamie B. Warren, Albert Manasyan, Elwyn Chomba, Ariel A.
Salas, Robert Schelonka and Waldemar A. Carlo
Pediatrics 2013;132;e128; originally published online June 3, 2013;
DOI: 10.1542/peds.2012-2030
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