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

Abstract BACKGROUND: Heat loss in the delivery room in very preterm infants is associated with increased mortality, hypothermia and other adverse outcomes. The Heat Loss Preventions (HeLP) trial was designed to address these outcomes and 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. STUDY DESIGN: The original HeLP trial was a randomized controlled trial of very preterm 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. RESULTS: There were 356 infants eligible for follow-up from the randomized controlled HeLP trial with a loss to follow-up of 116/356 (32.6%). The primary outcome occurred in 82/113 in the wrap group and 80/127 in the control group (p=0.149, Fisher’s exact). Because of the large loss to follow-up rate, this unadjusted odds ratio was 1.55 (95% confidence interval=0.90-2.69) while the adjusted odds ratio (adjusted for major predictors of the outcome) was virtually unchanged at 1.52 (95% confidence interval=0.83-2.80). Secondary outcomes in the wrap versus control group were: cerebral palsy 9/70 versus 5/87 (p=0.204, Fisher’s exact), Mental Developmental Index (MDI) < 85 (Bayley Scales) 30/53 versus 33/67 (p=0.538, Fisher’s exact), blindness at 0/68 versus 1/86 (p>0.999, Fisher’s exact) and deafness 5/70 versus 6/87 (p>0.999, Fisher’s exact). No difference was noted in prescription glasses, 7/70 in the wrap group versus 2/87 in the control group (p=0.085, Fisher’s exact). CONCLUSION: Use of polyethylene occlusive wrap after birth in very preterm infants was associated with similar death or long-term neurodevelopmental disability rate. Clinical Trials Registry: Clinicaltrials.gov NCT00607464