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

Hypothermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01604317
• Other study ID #: UAB Neo 005
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2012
• Est. completion date: August 15, 2024

Study information

• Verified date: August 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 182
• Est. completion date: August 15, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute to 1 Hour

Eligibility

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

Related Conditions & MeSH terms

• Hypothermia
• Immature Newborn

Intervention

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.
• 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.

Locations

Country	Name	City	State
Zambia	University Teaching Hospital	Lusaka

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Children's Health System, Alabama

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Seizure	Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.	Up to 4 weeks
Secondary	Respiratory Distress Syndrome (RDS)	Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant	Up to 4 weeks
Secondary	Pneumothorax	Either chest radiograph documentation or clinical deterioration consistent with air leak	Up to 4 weeks
Secondary	Sepsis	Culture proven or culture negative clinically treated course consistent with sepsis	Up to 4 weeks
Secondary	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
Secondary	Death	Cardiorespiratory failure	Up to 4 weeks
Secondary	Hyperthermia	Axillary temperature > 38 degrees Celsius per temperature taken per axilla for one minute	Up to 4 weeks
Secondary	Temperature and humidity	A recording of the room temperature and humidity will be obtained with each axillary temperature measurement	1-72 hours after birth