Randomized trial of occlusive wrap for heat loss prevention in preterm infants: neurodevelopmental outcome

Heat loss in the delivery room in very preterm infants is associated with increased mortality, hypothermia and other adverse outcomes. The Heat Loss Prevention (HeLP) trial resulted in a significant reduction of hypothermia but not a reduction in mortality. The HeLP follow-up trial was designed to determine whether application of occlusive wrap applied immediately after birth reduces adverse long-term neurodevelopmental outcomes at 18-24 months corrected gestational age in very preterm infants.

The original HeLP trial was a randomized controlled trial in infants < 28 weeks gestation placed at birth in occlusive wrap (wrap group) or not placed in occlusive wrap (control group). The HeLP follow-up trial was the later assessment of these infants enrolled in the HeLP trial to determine the composite outcome of death or neurodevelopmental disability at 18-24 month corrected gestational age.

This report constitutes a description of outcome for a subgroup of infants enrolled at centers with perinatal follow-up programs. 356 infants were eligible for follow-up from the HeLP trial with a loss to follow-up of 116/356 (32.6%). The primary outcome occurred in 82/113 (72.6%) in the wrap group and 80/127 (63.0%) in the control group (p = 0.115). An unadjusted odds ratio was 1.55 (95% confidence interval = 0.90-2.69) and because of a large loss to follow-up, odds ratios adjusted for potential predictors of the outcome were determined and showed no differences in the primary outcome by group assignment. Secondary outcomes in the wrap versus control group were: cerebral palsy 9/70 (12.9%) versus 5/87 (5.7%) (p = 0.20), Mental Developmental Index < 85 (Bayley Scales) 30/53 (56.6%) versus 33/67 (49.3%) (p = 0.54), blindness at 0/68 (0.0%) versus 1/86 (1.2%) (p > 0.99) and deafness 5/70 (7.1%) versus 6/87 (6.9%) (p > 0.99). No difference was noted in prescription glasses, 7/70 (10.0%) in the wrap group versus 2/87 (2.2%) in the control group (p = 0.09).

Use of polyethylene occlusive wrap after birth in very preterm infants was associated with similar death or long-term neurodevelopmental disability rate.

This trial was registered with Clinicaltrials.gov NCT00607464 on 22 January 2008. Ethics approval was provided by each site and held Mount Sinai Hospital Research Ethics Board (15-0243-C; 7 October 2015).