At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part IV
In Brief
A Phase 4 clinical trial evaluating Hypothermia prevention with plastic bag and Hypothermia prevention without plastic bag for Hypothermia. Completed, enrolled 118 participants across 1 site.
Detailed Summary
The overall hypothesis is that plastic bags used in combination with WHO thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine WHO thermoregulation care alone. Part V is comparing use of a plastic torso wrap to no plastic torso wrap in preterm/low birth weight infants following removal from their incubator to assist with temperature regulation.
Study Details
Timeline
Interventions
Upon removal from the incubator, infant will be placed into a plastic bag to his/her axillae, and the bag will be folded and taped to itself to prevent it from covering the infant's nose or mouth. The infant will be wrapped in a blanket and receive a cloth hat. The bag will be changed when soiled and the infant will remain in the bag for 72 hours or until discharge, whichever comes first. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.
Upon removal from incubator, the infant will be wrapped in a blanket and receive a cloth hat, according to standard bundling practices. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.