Warming Mattress Versus Polyethylene Wrapping to Prevent Hypothermia in Preterm Newborns.
Mean axillary temperatures, taken during NICU resuscitation upon admission to the NICU, will not differ between VLBW babies who are occlusively wrapped and very low birth weight (VLBW) babies who are placed on thermal warming blankets.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Thermal Defense of Extremely Low Gestational Age Newborns (ELGANs) During Resuscitation: Exothermic Mattresses vs. Polyethylene Wrap|
- Neonatal Intensive Care Unit (NICU) Admission Temperature [ Time Frame: At time of admission to the NICU - usually within 10-15 min of birth ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2007|
|Study Completion Date:||November 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
This arm includes those Extremely low gestational age newborns (ELGANs) who are to be placed on a sodium acetate warming blanket after delivery.
A gel blanket containing a sodium acetate-based medium that, when activated, becomes exothermic and provides heat.
This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
This is a polyethylene wrap that will be placed around the ELGAN from the neck down to prevent heat loss.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603837
|United States, Oklahoma|
|Oklahoma University Health Sciences Center|
|Oklahoma City, Oklahoma, United States, 73104|
|Principal Investigator:||Douglas Dannaway, MD||University of Oklahoma|
|Study Director:||Parker L Simon, DO, MPH||University of Oklahoma|
|Study Chair:||Marilyn Escobedo, MD||University of Oklahoma|