Warming Mattress Versus Polyethylene Wrapping to Prevent Hypothermia in Preterm Newborns.
|ClinicalTrials.gov Identifier: NCT00603837|
Recruitment Status : Completed
First Posted : January 29, 2008
Results First Posted : September 2, 2009
Last Update Posted : October 16, 2009
|Condition or disease||Intervention/treatment|
|Hypothermia||Device: NeoWrap Device: InfaTherm|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Thermal Defense of Extremely Low Gestational Age Newborns (ELGANs) During Resuscitation: Exothermic Mattresses vs. Polyethylene Wrap|
|Study Start Date :||May 2007|
|Primary Completion Date :||November 2008|
|Study Completion Date :||November 2008|
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.
- Neonatal Intensive Care Unit (NICU) Admission Temperature [ Time Frame: At time of admission to the NICU - usually within 10-15 min of birth ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|