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

NCT01604434 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-02-20

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 III is for preterm/low birth weight infants with or without a plastic torso wrap during the first hour after birth to assist with temperature regulation during placement in an incubator.

Conditions

  • Hypothermia

Interventions

PROCEDURE

Incubator-torso bag

While being placed into an 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 over the plastic bag and will receive a cloth hat. He/she will remain in the bag for one hour.

PROCEDURE

Incubator-no plastic bag

Infant will be placed in the incubator, wrapped in a blanket, with a cloth hat, according to standard protocol.

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
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2018-10-31
Completion
2019-10-31

Countries

  • Zambia

Study Locations

More Related Trials

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 NCT01604434 on ClinicalTrials.gov