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
4 other identifiers
interventional
182
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2012
CompletedFirst Posted
Study publicly available on registry
May 23, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 15, 2026
September 16, 2025
August 1, 2025
14.2 years
May 21, 2012
September 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Axillary temperature < 36.5 degrees Celsius
Temperature taken per axilla at one hour after birth. Temperatures 36.0-36.4 will be classified as mild hypothermia, 32.0-35.9 will be classified as moderate hypothermia, and \< 32.0 will be classified as severe hypothermia
1-72 hours after birth
Secondary Outcomes (8)
Seizure
Up to 4 weeks
Respiratory Distress Syndrome (RDS)
Up to 4 weeks
Pneumothorax
Up to 4 weeks
Sepsis
Up to 4 weeks
Necrotizing enterocolitis or intestinal perforation
Up to 4 weeks
- +3 more secondary outcomes
Study Arms (2)
Resuscitation-torso plastic bag
ACTIVE COMPARATORResuscitation with plastic bag covering torso and lower extremities for first hour to assist with temperature regulation.
Resuscitation-partial-head plastic bag
ACTIVE COMPARATORResuscitation with plastic bag covering torso, upper and lower extremities, and a portion of the head for first hour after birth to assist with temperature regulation.
Interventions
Infant's extremities and torso will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth.
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.
Eligibility Criteria
You may qualify if:
- Estimated gestational age 29-36 6/7weeks or birth weight 1,400-2500g
- Delivery in the hospital
You may not qualify if:
- Infant admitted to the NICU
- Birth weight less than 1,400g
- Abdominal wall defect or myelomeningocele
- Major congenital anomalies
- Blistering skin disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Teaching Hospital
Lusaka, Zambia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Waldemar A Carlo, MD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Edwin M. Dixon Professor of Pediatrics, Director of Division of Neonatology
Study Record Dates
First Submitted
May 21, 2012
First Posted
May 23, 2012
Study Start
June 1, 2012
Primary Completion (Estimated)
August 15, 2026
Study Completion (Estimated)
August 15, 2026
Last Updated
September 16, 2025
Record last verified: 2025-08