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

Hypothermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01604421
• Other study ID #: UAB Neo 007
• Status: Withdrawn
• Phase: N/A
• Start date: February 2013
• Est. completion date: October 2019

Study information

• Verified date: February 2019
• 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 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.

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%.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 120 Days

Eligibility

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

Related Conditions & MeSH terms

• Hypothermia

Intervention

Procedure:
• 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.
• 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.

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 as severe hypothermia.	Discharge or 24 hours after birth
Secondary	Seizure	Seizure activity diagnosed by medical director 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 1.	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