Status:
COMPLETED
Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Hypothermia, Newborn
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
The overall hypothesis is that placing infants 1000-2500 grams in plastic bags when compared to routine care will reduce the risk of hypothermia (\< 36.5 degrees C) without increasing hyperthermia (\>...
Detailed Description
Prevention After consent, infants with estimated gestational age between 26-36.6 weeks or with expected birth weight 1000-2500 grams will be randomized to resuscitation per standard protocol or to re...
Eligibility Criteria
Inclusion
- Estimated gestational age 26-36.6 weeks or expected birth weight 1000-2500 grams.
- Delivery in the hospital.
Exclusion
- Abdominal wall defect or myelomeningocele.
- Major congenital anomaly.
- Blistering skin disorder.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT01403623
Start Date
August 1 2011
End Date
December 1 2012
Last Update
August 21 2013
Active Locations (1)
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1
University Teaching Hospital
Lusaka, Zambia