Heat Loss Prevention Trial (HeLP)

Purpose
To investigate the effect on mortality of a polyethylene occlusive wrap applied immediately after delivery

Study Design
Two-intervention, parallel randomized control trial design. Preterm infants meeting the eligibility criteria were randomly assigned within three gestational age strata (less than 24 weeks, 24+0 to 25+6 weeks gestation, and 26+0 to 27+6 weeks gestation) to either the occlusive skin wrap group or the standard of care (non-wrap) group.

Primary Outcome
To determine if polyethylene occlusive wrap applied immediately after delivery to infants born between 24+0 and 27+6 weeks gestation resulted in decreased mortality compared with the conventional method of drying. Because of increased mortality and variable center specific resuscitation practices, infants born at less than 24 weeks gestation were randomized as part of a optional separate pilot study .

Secondary Outcomes

  • Axillary temperature taken on introduction into a warm environment in the NICU
  • Acidosis, hypotension, hypoglycaemia, seizures, patent ductus arteriosus, respiratory distress syndrome/chronic lung disease, necrotizing enterocolitis and head ultrasound results
  • Length of stay and cause of death at discharge

Long-term follow-up is critical to understanding the implications of any new intervention. As such, hospitals that agreed to participate in the follow-up study asked parents for permission to contact them approximately 18-24 months after birth.

Publications
Reilly MC, Vohra S, Rac VE, Dunn M, Ferrelli K, Kiss A, Vincer M, Wimmer J, Zayack D, Soll RF; Vermont Oxford Network Heat Loss Prevention (HeLP) Trial Study Group. Randomized trial of occlusive wrap for heat loss prevention in preterm infants. Journal of Pediatrics. 2014 (epub ahead of print). PubMed: 25449224

Vohra S, Reilly M, Rac VE, Bhaloo Z, Zayack D, Wimmer J, Vincer M, Ferrelli K, Kiss A, Soll R, Dunn M. Study protocol for multicentre randomized controlled trial of HeLP (Heat Loss Prevention) in the delivery room. Contemp Clin Trials. 2013;36(1): 54-60. PubMed: 23770234

Study Sponsors
Canadian Institute of Health Research (CIHR)