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

NCT01604317 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2025-09-16

No results posted yet for this study

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.

Conditions

  • Hypothermia
  • Immature Newborn

Interventions

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.

Sponsors & Collaborators

  • Children's Health System, Alabama

    collaborator OTHER

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Waldemar A Carlo, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
1 Hour
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2026-08-15
Completion
2026-08-15

Countries

  • Zambia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01604317 on ClinicalTrials.gov