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

Phase 4

Completed

• Conditions: Hypothermia; Newborn
• Interventions: Procedure: Resuscitation-no plastic bag; Procedure: Resuscitation with torso plastic bag

• Registration Number: NCT01604460
• Lead Sponsor: University of Alabama at Birmingham

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 V is comparing standard WHO thermoregulation practices plus use of a plastic torso wrap to no plastic torso wrap in full term infants from resuscitation to one hour after birth.

Detailed Description

Due to delivery rooms without adequate climate controls, even full term infants have high rates of hypothermia in the developing world. This study will compare the rates of hypothermia one hour after birth in full term infants randomized to receive standard WHO thermoregulation care (control group) or standard WHO thermoregulation care without immediate drying plus a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken within 15 minutes of birth at at one hour after birth with removal of the plastic bag. Hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 15% and a hypothesized 10% absolute risk reduction (66% relative risk reduction), a sample size of 276 will be used to have a power of 80% and a confidence interval of 95%.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2012-05-21
• Study First Submitted QC: 2012-05-21
• Study First Posted: 2012-05-23
• Study Start: 2012-06
• Primary Completion: 2012-08
• Study Completion: 2012-11
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-08
• Last Update Posted: 2013-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

• Estimated gestational age 37 weeks and greater
• Birth weight greater than 2,500gms
• Delivery in the hospital

Read More

Exclusion Criteria

• Infant admitted to the NICU
• Birth weight less than 2,500gms
• Abdominal wall defect or myelomeningocele
• Major congenital anomalies
• Blistering skin disorder

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resuscitation-no plastic bag	Resuscitation-no plastic bag	Resuscitation per standard of care without a plastic bag
Resuscitation-torso bag	Resuscitation with torso plastic bag	Use of plastic bag covering the torso and lower extremities for temperature regulation during and after resuscitation for the first hour after birth

Primary Outcome Measures

Name	Time	Method
Axillary temperature < 36.5 degrees Celsius	1-72 hours	Temperature taken per axilla at one hour after birth. Temperatures 36.0-16.4 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.

Secondary Outcome Measures

Name	Time	Method
Sepsis	Up to 72 hours	Culture proven or culture negative clinically treated course consistent with sepsis
Death	Up to 72 hours	Cardiorespiratory failure
Hyperthermia	Up to 72 hours	Axillary temperature \> 38 degrees Celsius per axilla for one minute
Room Temperature	1-72 hours	A recording of the room temperature will be obtained with each axillary temperature measurement

Trial Locations

Locations (1)

University Teaching Hospital; 🇿🇲 Lusaka, Zambia