Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
6151080 | Contemporary Clinical Trials | 2013 | 7 Pages |
IntroductionImmediate postnatal hypothermia is an independent risk factor for death in premature newborns. Three randomized controlled trials (RCTs) and five historical controlled trials show statistically significant differences in admission temperature between infants wrapped in occlusive skin wrap and unwrapped infants. This paper presents a study protocol for The Vermont Oxford Network (VON) Heat Loss Prevention (HeLP) Trial, a multicentre RCT of two interventions (standard of care vs. occlusive wrap) that investigates the effect of polyethylene occlusive wrap applied immediately after birth on mortality in infants born 24Â +Â 0/7 to 27Â +Â 6/7Â week gestation.MethodsInclusion criteria include: infants 24Â +Â 0/7 to 27Â +Â 6/7Â weeks gestational age and a firm decision prior to birth to provide full resuscitative measures. Exclusion criteria comprise infants born with blistering skin conditions or congenital anomalies that are not covered by skin. The primary outcome measure is all-cause mortality until discharge from the hospital or at six months corrected gestational age. The secondary outcome measures include baseline and post-stabilization axillary temperatures, acidosis, hypotension, hypoglycaemia, seizures in the first 12Â h, patent ductus arteriosus, and respiratory distress syndrome. Long-term follow-up at 18 to 24Â months corrected age will be assessed with the combined risk of death and major neurosensory disability as the primary outcome.DiscussionKey covariates and protocol deviations are addressed and steps to monitor these are described. Wrapping may prove an inexpensive and easy method to benefit premature newborns in level I and II nurseries, in both developed and developing countries, as well as large tertiary care centres.REB approvalSunnybrook Health Sciences Centre, Toronto, Ontario, Canada-355-2003University of Alberta, Edmonton, Alberta, Canada-Pro00003810Vermont Oxford Network, Burlington, Vermont, USA-CHRMS: M04-295