Status:
TERMINATED
Multicentre Randomised Controlled Trial of HELP (Heat Loss Prevention) in the Delivery Room
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Vermont Oxford Network
Conditions:
Hypothermia in Premature Infants
Eligibility:
All Genders
24-28 years
Phase:
NA
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 car...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
- \-
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
804 Patients enrolled
Trial Details
Trial ID
NCT00607464
Start Date
September 1 2004
End Date
October 1 2012
Last Update
April 25 2016
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5