Status:
COMPLETED
Plastic Hat Trial to Prevent Hypothermia in Preterm Newborns in the Delivery Room
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Hypothermia
Eligibility:
All Genders
Up to 1 years
Phase:
NA
Brief Summary
The purpose of this research project is to ascertain the effectiveness of plastic head covering in prevention of hypothermia. Hypothermia is defined by body temperature \<36.5º Celsius by the World He...
Detailed Description
A prospective randomized control trial will be conducted in Parkland Memorial Hospital (PMH) neonatal intensive care unit (NICU) Dallas, Texas. Consent will not be obtained since: placement of plastic...
Eligibility Criteria
Inclusion
- Infants with less than 33 week gestational age by obstetrical dating
- Infants delivered in Parkland Memorial Hospital Labor and Delivery areas
- Infant whose delivery was attended by the Parkland Neonatal Resuscitation Team
- Infant whos is viable
Exclusion
- Infant who has 33 week gestational age or greater by obstetrical dating
- Infant who is deemed non-viable
- Infant who did not have the Parkland Neonatal Resuscitation Team present at time of birth
- Infant with congenital anomaly which precludes measurement of rectal temperature (such as anal atresia or imperforate anus)
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00904228
Start Date
September 1 2008
End Date
December 1 2010
Last Update
April 25 2019
Active Locations (1)
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1
Parkland Memorial Hospital
Dallas, Texas, United States, 75390