Early Skin-to-Skin Care with a Polyethylene Bag for Neonatal Hypothermia: A Randomized Clinical Trial

Colm P. Travers, The University of Alabama at Birmingham
Manimaran Ramani, The University of Alabama at Birmingham
Samuel J. Gentle, The University of Alabama at Birmingham
Amelia Schuyler, The University of Alabama at Birmingham
Catherine Brown, Cincinnati Children's Hospital Medical Center
Madeline M. Dills, LSU Health Sciences Center- New Orleans
Claire B. Davis, UT Southwestern Medical Center
Musaku Mwenechanya, University of Zambia
Elwyn Chomba, University of Zambia
Inmaculada Aban, The University of Alabama at Birmingham
Albert Manasyan, The University of Alabama at Birmingham
Namasivayam Ambalavanan, The University of Alabama at Birmingham
Waldemar A. Carlo, The University of Alabama at Birmingham

Abstract

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.