CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 182 enrolled
Drug / intervention
Resuscitation-torso plastic bag +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01604317
NCT01604317N/AActive

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

University of Alabama at Birmingham·interventional·Posted May 23, 2012·Updated Sep 16, 2025

In Brief

A clinical study evaluating Resuscitation-torso plastic bag and Resuscitation-partial-head plastic bag for Hypothermia and Immature Newborn. Active but no longer recruiting, targeting 182 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 I is for preterm/low birth weight infant with or without plastic head cover used during resuscitation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesZambia

Timeline

N/AActive
2012201320142015201620172018201920202021202220232024202520262027
First PostedMay 23, 2012
Enrollment StartJun 1, 2012
Primary CompletionAug 15, 2026
TodayJul 1, 2026
Enrollment to primary: 14.2 yearsPosted 14.1 years agoPrimary completion in 1 month

Interventions

Resuscitation-torso plastic bagprocedure

Infant's extremities and torso will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth.

Resuscitation-partial-head plastic bagprocedure

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.