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

This study has been completed.
Sponsor:
Collaborator:
Children's Health System, Alabama
Information provided by (Responsible Party):
Waldemar A. Carlo, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01604460
First received: May 21, 2012
Last updated: February 8, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Hypothermia
Newborn
Procedure: Resuscitation with torso plastic bag
Procedure: Resuscitation-no plastic bag
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part V

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Axillary temperature < 36.5 degrees Celsius [ Time Frame: 1-72 hours ] [ Designated as safety issue: Yes ]
    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:
  • Sepsis [ Time Frame: Up to 72 hours ] [ Designated as safety issue: Yes ]
    Culture proven or culture negative clinically treated course consistent with sepsis

  • Death [ Time Frame: Up to 72 hours ] [ Designated as safety issue: Yes ]
    Cardiorespiratory failure

  • Hyperthermia [ Time Frame: Up to 72 hours ] [ Designated as safety issue: Yes ]
    Axillary temperature > 38 degrees Celsius per axilla for one minute

  • Room Temperature [ Time Frame: 1-72 hours ] [ Designated as safety issue: Yes ]
    A recording of the room temperature will be obtained with each axillary temperature measurement


Enrollment: 275
Study Start Date: June 2012
Study Completion Date: November 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Resuscitation-no plastic bag
Resuscitation per standard of care without a plastic bag
Procedure: 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.
Active Comparator: Resuscitation-torso bag
Use of plastic bag covering the torso and lower extremities for temperature regulation during and after resuscitation for the first hour after birth
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.

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%.

  Eligibility

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01604460

Locations
Zambia
University Teaching Hospital
Lusaka, Zambia
Sponsors and Collaborators
University of Alabama at Birmingham
Children's Health System, Alabama
Investigators
Principal Investigator: Waldemar A Carlo, MD University of Alabama at Birmingham
  More Information

No publications provided by University of Alabama at Birmingham

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Waldemar A. Carlo, MD, Edwin M. Dixon Professor of Pediatrics, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01604460     History of Changes
Other Study ID Numbers: UAB Neo 010
Study First Received: May 21, 2012
Last Updated: February 8, 2013
Health Authority: United States: Institutional Review Board
Zambia: Research Ethics Committee

Keywords provided by University of Alabama at Birmingham:
Hypothermia
Newborn
Plastic bag
Resuscitation

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014