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

Hypothermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604460
• Other study ID #: UAB Neo 010
• Status: Completed
• Phase: Phase 4
• First received: May 21, 2012
• Last updated: February 8, 2013
• Start date: June 2012
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardZambia: Research Ethics Committee
• 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 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: November 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 72 Hours

Eligibility

Inclusion Criteria:

• Estimated gestational age 37 weeks and greater

• Birth weight greater than 2,500gms

• Delivery in the hospital

Exclusion Criteria:

• Infant admitted to the NICU

• Birth weight less than 2,500gms

• Abdominal wall defect or myelomeningocele

• Major congenital anomalies

• Blistering skin disorder

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypothermia
• Newborn

Intervention

Procedure:
• Resuscitation with torso plastic bag
Infant will be placed within 10 minutes of his birth into a plastic bag 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. After his/her head is dried, the infant will receive a cloth cap. Resuscitation will occur in the delivery room and the infant will be wrapped in a blanket and taken to the nursery where he/she will remain in the plastic bag until 1 hour after birth.
• Resuscitation-no plastic bag
Infant will be immediately dried and resuscitated in the delivery room per standard of care. The infant will be wrapped in a blanket and will receive a cloth hat before being taken to the nursery.

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 36.0-16.4 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.	1-72 hours	Yes
Secondary	Sepsis	Culture proven or culture negative clinically treated course consistent with sepsis	Up to 72 hours	Yes
Secondary	Death	Cardiorespiratory failure	Up to 72 hours	Yes
Secondary	Hyperthermia	Axillary temperature > 38 degrees Celsius per axilla for one minute	Up to 72 hours	Yes
Secondary	Room Temperature	A recording of the room temperature will be obtained with each axillary temperature measurement	1-72 hours	Yes