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

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 Overview

• Status: Active, not recruiting
• Conditions: Hypothermia; Immature Newborn
• Intervention / Treatment: Procedure: Resuscitation-torso plastic bag; Procedure: Resuscitation-partial-head plastic bag

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%.

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Zambia
  • Lusaka, Zambia
    • University Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 1 hour (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Estimated gestational age 29-36 6/7weeks or birth weight 1,400-2500g
• Delivery in the hospital

Exclusion Criteria:

• Infant admitted to the NICU
• Birth weight less than 1,400g
• Abdominal wall defect or myelomeningocele
• Major congenital anomalies
• Blistering skin disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Resuscitation-torso plastic bag; Resuscitation with plastic bag covering torso and lower extremities for first hour to assist with temperature regulation.	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.
Active Comparator: Resuscitation-partial-head plastic bag; Resuscitation 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure	Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.	Up to 4 weeks
Respiratory Distress Syndrome (RDS)	Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant	Up to 4 weeks
Pneumothorax	Either chest radiograph documentation or clinical deterioration consistent with air leak	Up to 4 weeks
Sepsis	Culture proven or culture negative clinically treated course consistent with sepsis	Up to 4 weeks
Necrotizing enterocolitis or intestinal perforation	Documentation of pneumatosis or intestinal perforation on x-ray or treatment course for clinical necrotizing enterocolitis per Bell's classification stage greater than one.	Up to 4 weeks
Death	Cardiorespiratory failure	Up to 4 weeks
Hyperthermia	Axillary temperature > 38 degrees Celsius per temperature taken per axilla for one minute	Up to 4 weeks
Temperature and humidity	A recording of the room temperature and humidity will be obtained with each axillary temperature measurement	1-72 hours after birth

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Children's Health System, Alabama
• Investigators: Principal Investigator: Waldemar A Carlo, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2012
• Primary Completion (Estimated): August 15, 2024
• Study Completion (Estimated): August 15, 2024

Study Registration Dates

• First Submitted: May 21, 2012
• First Submitted That Met QC Criteria: May 21, 2012
• First Posted (Estimated): May 23, 2012

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Hypothermia; Newborn; Resuscitation; Low birth Weight; Plastic bag
• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: UAB Neo 005