title: Study protocol for multicentre randomized controlled trial of HeLP (Heat Loss Prevention) in the delivery room.
abstract: BACKGROUND
  Immediate 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 24 + 0/7 to 27 + 6/7 week gestation.
  
  
  METHODS
  Inclusion criteria include: infants 24 + 0/7 to 27 + 6/7 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 12h, patent ductus arteriosus, and respiratory distress syndrome. Long-term follow-up at 18 to 24 months corrected age will be assessed with the combined risk of death and major neurosensory disability as the primary outcome.
  
  
  CONCLUSIONS
  Key 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.
  Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada-355-2003 University of Alberta, Edmonton, Alberta, Canada-Pro00003810 Vermont Oxford Network, Burlington, Vermont, USA-CHRMS: M04-295.
authors.affiliation: Department of Paediatrics, Faculty of Medicine & Dentistry, University of Alberta, Edmonton, Alberta, Canada. svohra@ualberta.ca
authors.forename: Sunita
authors.initials: S
authors.lastname: Vohra
authors.forename: Maureen
authors.initials: M
authors.lastname: Reilly
authors.forename: Valeria E
authors.initials: VE
authors.lastname: Rac
authors.forename: Zafira
authors.initials: Z
authors.lastname: Bhaloo
authors.forename: Denise
authors.initials: D
authors.lastname: Zayack
authors.forename: John
authors.initials: J
authors.lastname: Wimmer
authors.forename: Michael
authors.initials: M
authors.lastname: Vincer
authors.forename: Karla
authors.initials: K
authors.lastname: Ferrelli
authors.forename: Alex
authors.initials: A
authors.lastname: Kiss
authors.forename: Roger
authors.initials: R
authors.lastname: Soll
authors.forename: Michael
authors.initials: M
authors.lastname: Dunn
mesh_terms: D001831:Body Temperature; D002675:Child, Preschool; D002985:Clinical Protocols; D003696:Delivery Rooms; D005260:Female; D005865:Gestational Age; D017052:Hospital Mortality; D006801:Humans; D007035:Hypothermia / Q000150:complications / Q000401:mortality* / Q000517:prevention & control*; D007226:Infant Mortality; D007231:Infant, Newborn; D007234:Infant, Premature; D008297:Male; D020959:Polyethylene; D012107:Research Design
chemical_list: D020959:Polyethylene
keywords: Hypothermia; Occlusive skin wrap; Polyethylene wrap; Postnatal heat loss; Premature newborn