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

NCT ID: NCT01604421

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2019-10-31

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 II is for preterm/low birth weight infant with or without plastic head cover used from 1 hour after birth until discharge or 24 hours after birth to assist with temperature regulation.

Detailed Description

Due to limited resources, hospitals in the developing world struggle to provide sufficient incubators and to maintain climate-controlled nurseries. Therefore, premature low birth weight infants continue to be at an increased risk of hypothermia throughout their hospitalizations. This study will compare the incidence of hypothermia in preterm/low birth weight infants randomized to receive WHO thermoregulation care (control groups) or WHO thermoregulation care and a plastic bag covering their torsos and lower extremities (intervention group) starting at one hour after birth and continued to discharge or 24 hours after birth, whichever occurs first. The axillary temperature of each infant will be taken one hour after birth, every subsequent 3-4 hours, and at discharge or 24 hours after birth when infants will be removed from the plastic bags. Seizures, hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 50% and a hypothesized 20% absolute risk reduction (40% relative risk reduction), a sample size of 182 will be used to have a power of 80% and a confidence interval of 95%.

Conditions

Hypothermia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Thermoregulation-standard care

Standard thermoregulation without a plastic bag from one hour after birth until discharge or 24 hours after birth, whichever comes first.

Group Type: SHAM_COMPARATOR

Thermoregulation-standard care

Intervention Type: PROCEDURE

Standard care without plastic bag. One hour after birth, a blanket will be wrapped around the infant and he/she will receive a wool hat, according to standard practices. The infant's axillary temperature will be monitored for 24 hours or until discharge, whichever comes first.

Thermoregulation-with plastic bag

Thermoregulation with plastic bag covering torso and lower extremities from one hour after birth until discharge or 24 hours after birth to assist with thermoregulation. The infant's axillary temperature will be monitored for 24 hours or until discharge, whichever comes first.

Group Type: ACTIVE_COMPARATOR

Thermoregulation with plastic bag

Intervention Type: PROCEDURE

One hour after birth, the infant will be placed into a plastic bag up 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. A blanket will be wrapped around the infant, and he/she will receive a wool hat. The infant will remain in the bag, which will be changed when soiled, for 24 hours or until discharge, whichever occurs first.

Interventions

Thermoregulation-standard care

Standard care without plastic bag. One hour after birth, a blanket will be wrapped around the infant and he/she will receive a wool hat, according to standard practices. The infant's axillary temperature will be monitored for 24 hours or until discharge, whichever comes first.

Intervention Type: PROCEDURE

Thermoregulation with plastic bag

One hour after birth, the infant will be placed into a plastic bag up 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. A blanket will be wrapped around the infant, and he/she will receive a wool hat. The infant will remain in the bag, which will be changed when soiled, for 24 hours or until discharge, whichever occurs first.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Estimated gestational age 29-36 6/7 weeks or birth weight 1400-2500g
• Delivery in the hospital

Exclusion Criteria

• Infant admitted to the NICU
• Birth weight less than 1400 gms
• Abdominal wall defect or myelomeningocele
• Major congenital anomalies
• Blistering skin disorder

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 120 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Health System, Alabama

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Wally Carlo

Edwin M. Dixon Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Waldemar A Carlo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University Teaching Hospital

Lusaka, , Zambia

Countries

Zambia

Other Identifiers

UAB Neo 007

Identifier Type: -

Identifier Source: org_study_id