Multicentre randomised controlled trial of HELP (heat loss prevention) in the delivery room

Not Applicable

Completed

• Conditions: Hypothermia; Hypothermia in premature infants; Neonatal Diseases

• Registration Number: ISRCTN85045728
• Lead Sponsor: niversity of Alberta and Sunnybrook and Women's College Health Sciences Centre (Canada) and The Vermont Oxford Network (USA)

Brief Summary

1. 2013 protocol in https://www.ncbi.nlm.nih.gov/pubmed/23770234 (added 07/02/2019) 2. 2015 results in https://www.ncbi.nlm.nih.gov/pubmed/25449224 (added 07/02/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-09
• Study Completion: 2008-10-31
• Last Update Posted: 4 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1685

Inclusion Criteria

Infants born at less than 28 weeks (aged 0 - 27 days, either sex) whose delivery is considered imminent and have consented (written) to participate in the trial. Prior to birth a firm decision to provide full resuscitative measures and intensive support must be made.

Exclusion Criteria

1. Infants born with major congenital anomalies that are not covered by skin (e.g. gastroschisis, meningomyelocele)
2. Infants whose deliveries are not attended by the neonatal team (e.g. precipitous delivery on route to the labour suite)
3. Infants born with blistering skin conditions that preclude the use of occlusive wrap

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death to discharge or at six months corrected gestational age

Secondary Outcome Measures

Name	Time	Method
<br> 1. Axillary temperature upon arrival in Neonatal Intensive Care Unit (NICU)<br> 2. Apgar scores, incidence of acidosis, hypotension, hypoglycaemia, seizures in the first 12 hours of life<br> 3. Patent ductus arteriosus, respiratory distress, syndrome/chronic lung disease, necrotizing enterocolitis/GI perforation, Retinopathy of Prematurity, sepsis, hearing, pneumothorax, intraventricular Haemorrhage/periventricular leukomalacia, pulmonary hemorrhage all measured at 36 weeks corrected gestational age, or at time of death or discharge home<br> 4. Death and neurosensory disability measured at 18 months corrected gestational age<br>