Early Skin-to-Skin Care with a Polyethylene Bag for Neonatal Hypothermia: A Randomized Clinical Trial - 22/03/21
, Manimaran Ramani, MD 1, Samuel J. Gentle, MD 1, Amelia Schuyler, MD 1, Catherine Brown, MD 2, Madeline M. Dills, MD 3, Claire B. Davis, MD 4, Musaku Mwenechanya, MBChB 5, Elwyn Chomba, MBChB, MPH 5, Inmaculada Aban, PhD 6, Albert Manasyan, MD 1, Namasivayam Ambalavanan, MD 1, Waldemar A. Carlo, MD 1Abstract |
Objective |
To determine whether early polyethylene bag use with skin-to-skin care compared with skin-to skin care alone reduce hypothermia among infants born at term in resource-limited settings.
Study design |
Infants born at term in the tertiary referral center in Lusaka, Zambia, were randomized using sequentially numbered sealed opaque envelopes in 2 phases: after birth (phase 1) and at 1 hour after birth (phase 2) to either skin-to-skin care with polyethylene bags or skin-to-skin care alone. Infant and maternal temperatures were recorded at birth, 1 hour, and every 4 hours until discharge or 24 hours.
Results |
We enrolled 423 infants from May 2017 to August 2017. The rate of moderate-severe hypothermia (temperature <36.0°C) at 1 hour was 72 of 208 (34.6%) in the skin-to-skin care with a polyethylene bag group compared with 101 of 213 (47.4%) in the skin-to-skin care alone group (relative risk, 0.71; 95% CI 0.56-0.90; P < .01; number needed to treat = 8). phase 1 treatment assignment significantly modified the effect of phase 2 treatment (P = .02 for interaction effect). Among infants randomized to skin-to-skin care with a polyethylene bag in phase 1, the risk of moderate-severe hypothermia was decreased in infants randomized to continue this intervention until discharge compared with infants randomized to skin-to-skin care alone. The rates of severe hypothermia, hyperthermia, and other adverse events did not differ significantly between groups.
Conclusions |
Low-cost polyethylene bags started after birth in combination with skin-to-skin care reduced moderate or severe hypothermia at 1 hour and at discharge among infants born at term in a resource-limited setting compared with skin-to-skin care alone.
Trial Registration |
ClinicalTrials.gov: NCT03141723.
Le texte complet de cet article est disponible en PDF.Keywords : infant, newborn, hyperthermia, hypothermia, thermoregulation, plastic bag, plastic wrap, polyethylene wrap, global health, perinatal, kangaroo mother care
Abbreviations : NICU, NNT, RR
Plan
| Supported by grants from the Perinatal Health and Human Development Research Program of the University of Alabama at Birmingham, the Children's of Alabama Centennial Scholar Fund, and the Caduceus Club of the University of Alabama School of Medicine. The funders of this study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report. W.C. serves on the board of MEDNAX, Inc. The other authors declare no conflicts of interest. |
Vol 231
P. 55 - avril 2021 Retour au numéro
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