Parallel Exploratory RCT of Polyethylene Wrap for Heat Loss Prevention in Infants Born at Less than 24 Weeks' Gestation

Background: The treatment effect of occlusive wrap applied immediately after delivery in infants born 24-28 weeks' gestation has been studied, but the effect is not known in infants born at less than 240/7 weeks' gestation.

Objectives: To determine if the use of occlusive wrap applied immediately after birth in infants born at less than 240/7 weeks' gestation results in any differences in outcomes when compared to non-wrapped infants.

Methods: Parallel exploratory randomized controlled trial with a convenience sample of 28 inborn infants born at less than 240/7 weeks' gestation enrolled during the duration of the HeLP trial. Infants were randomized to either the wrap or standard of care (no wrap) group.

Results: Twenty-eight infants (wrap n = 14; no wrap n = 14) were randomized and data on all infants was available for intention-to-treat analysis. There were no differences in baseline population characteristics. There was no statistically significant difference in mortality (n = 8/14 wrap, 8/14 no wrap). There was no statistically significant difference in baseline temperature (35.9°C, SD = 1.12, wrap vs. 35.1°C, SD = 1.16, no wrap, p = 0.16) or post-stabilization temperature (36.4°C, SD = 0.84, wrap vs. 36.1°C, SD = 1.2, no wrap, p = 0.56). There was a trend towards increased baseline temperature in the wrap group.

Conclusion: Application of occlusive wrap to infants born at less than 240/7 weeks' gestation immediately after birth did not reduce mortality or effect baseline or post-stabilization temperature in this small exploratory study. This small sample provides the first estimate of treatment effect for this high-risk population.