Clinical trial NCT00607464: Multicentre Randomised Controlled Trial of HELP (Heat Loss Prevention) in the Delivery Room
Official title: Multicentre Randomised Controlled Trial of HELP (Heat Loss Prevention) in the Delivery Room
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypothermia in Premature Infants
Keywords: Hypothermia, premature infants, Polyethylene occlusive wrap
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Vermont Oxford Network
name: University of Alberta
First posted: 2008-02-05
Enrollment: 804
Sex: ALL
Minimum age (years): 24
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Does polyethylene occlusive wrap applied immediately after delivery to infants born at less than 28 weeks gestation decrease all-cause mortality measured at discharge compared with the standard of care as determined by the Neonatal Resuscitation Program guidelines (i.e. drying under radiant heat)?

Detailed description: Thermoregulation is a major problem for low birth weight infants. The EPICure study showed that 36% of infants born between 24 and 25 weeks gestation had an admission temperature less than 35 degrees Celsius. Hypothermia is associated with increased risk of morbidity and mortality. The HeLP trial hopes to address these issues with the use of a polyethylene occlusive wrap applied immediately after delivery to infants born at less that 28 weeks gestation. Forty-five centers are currently involved in this study. Infant enrollments began in December 2004.

Primary outcome: To determine if polyethylene occlusive wrap applied immediately after delivery to infants born between 24+0 and 27+6 weeks gestation results 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 will be randomized as part of a separate Pilot Study and centers may choose if they wish to participate in this group or not. Secondary outcome: The key secondary outcome will be axillary temperature taken on introduction into a warm environment in the NICU. We will also record clinically important variables including: 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 will also be recorded. Long-term follow-up is critical to our understanding of the implications of any new intervention. As such, we ask parents from hospitals who agree to participate in the follow-up study for permission to contact them approximately 18 months after birth.

Preterm infants meeting the eligibility criteria will be 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.

Eligibility criteria: Inclusion Criteria:Infants born at less than 28 weeks and who have prior to birth a firm decision to provide full resuscitative measures and intensive support.

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Exclusion Criteria:1. Infants born with major congenital anomalies that are not covered by skin (e.g. gastroschisis, meningomyelocele) 2. Infants born with blistering skin conditions that preclude the use of occlusive wrap

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Primary outcomes:
measure: Death to discharge or at six months corrected gestational age
timeFrame: discharge or six months corrected gestational age
Secondary outcomes:
measure: 1. Axillary temperature upon arrival in Neonatal Intensive Care Unit (NICU)
timeFrame: upon arrival in NICU
measure: acidosis, hypotension, hypoglycaemia, seizures
timeFrame: first 12 hours of life
measure: 4. Death and neurosensory disability measured at 18 months corrected gestational age
timeFrame: 18 months corrected gestational age
measure: PDA, RDS, CLD, pneumothorax, sepsis, IVH, PVL, NEC, GI perforation, pulmonary hemorrhage, hearing, ROP
timeFrame: discharge from hospital or 6 months corrected gestational age
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Maureen C Reilly, RRT
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta/Stollery Children's Hospital
name: Sunita Vohra, MD FRCPC MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. J Pediatr. 2015 Feb;166(2):262-8.e2. doi: 10.1016/j.jpeds.2014.09.068. Epub 2014 Nov 12.
citation: 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 Sep;36(1):54-60. doi: 10.1016/j.cct.2013.06.001. Epub 2013 Jun 11.