NCT01604317

Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part I

Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part I

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 1 Minute – 1 Hour
• Healthy volunteers: Not accepted

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 I is for preterm/low birth weight infant with or without plastic head cover used during resuscitation.

Detailed description

This study will compare the incidence of hypothermia during the first hour after birth in preterm/low birth weight infants randomized to receive WHO thermoregulation care and a plastic bag (without drying) covering the torso and lower extremities (control group) or WHO thermoregulation care and a plastic bag (without drying) covering the torso, upper and lower extremities, and a portion of their head (intervention group). The axillary temperature of each infant will be taken initially within 15 minutes of birth and later at 1 hour after birth as the infant is removed from the plastic bag. Seizures, hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 41% and a 21% absolute risk reduction (51% relative risk reduction), a sample size of 182 will be used to have a power of 80% and a confidence interval of 95%.

Conditions

• Hypothermia
• Immature Newborn

Interventions

Type	Name	Description
PROCEDURE	Resuscitation-torso plastic bag	Infant's extremities and torso will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth.
PROCEDURE	Resuscitation-partial-head plastic bag	Infant's torso, extremities, and portion of the head (face will be exposed) will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth.

Timeline

• Start date: 2012-06-01
• Primary completion: 2026-08-15
• Completion: 2026-08-15
• First posted: 2012-05-23
• Last updated: 2025-09-16

Locations

1 site across 1 country: Zambia