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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Alabama at Birmingham
Sponsor:
Collaborator:
Children's Health System, Alabama
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01604317
First received: May 21, 2012
Last updated: May 30, 2014
Last verified: May 2014
  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 I is for preterm/low birth weight infant with or without plastic head cover used during resuscitation.


Condition Intervention Phase
Hypothermia
Immature Newborn
Procedure: Torso bag during resuscitation
Procedure: Partial head covering plastic bag during resuscitation
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 I

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 after birth ] [ Designated as safety issue: Yes ]
    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 will be classified as severe hypothermia


Secondary Outcome Measures:
  • Seizure [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
    Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.

  • Respiratory Distress Syndrome (RDS) [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
    Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant

  • Pneumothorax [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
    Either chest radiograph documentation or clinical deterioration consistent with air leak

  • Sepsis [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
    Culture proven or culture negative clinically treated course consistent with sepsis

  • Necrotizing enterocolitis or intestinal perforation [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
    Documentation of pneumatosis or intestinal perforation on x-ray or treatment course for clinical necrotizing enterocolitis per Bell's classification stage greater than one.

  • Death [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
    Cardiorespiratory failure

  • Hyperthermia [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
    Axillary temperature > 38 degrees Celsius per temperature taken per axilla for one minute

  • Temperature and humidity [ Time Frame: 1-72 hours after birth ] [ Designated as safety issue: No ]
    A recording of the room temperature and humidity will be obtained with each axillary temperature measurement


Estimated Enrollment: 182
Study Start Date: June 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Resuscitation-torso plastic bag
Resuscitation with plastic bag covering torso and lower extremities for first hour to assist with temperature regulation.
Procedure: Torso bag during resuscitation
Infant's extremities and torso will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth.
Active Comparator: Resuscitation-partial head covering plastic bag
Resuscitation with plastic bag covering torso, upper and lower extremities, and a portion of the head for first hour after birth to assist with temperature regulation.
Procedure: Partial head covering plastic bag during resuscitation
Infant's torso, extremities, and portion of the head (face will be exposed) will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth.

Detailed Description:

This study will compare the incidence of hypothermia during the first hour after birth in preterm/low birth weight infants randomized to receive WHO thermoregulation care and a plastic bag (without drying) covering the torso and lower extremities (control group) or WHO thermoregulation care and a plastic bag (without drying) covering the torso, upper and lower extremities, and a portion of their head (intervention group). The axillary temperature of each infant will be taken initially within 15 minutes of birth and later at 1 hour after birth as the infant is removed from the plastic bag. Seizures, hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 41% and a 21% absolute risk reduction (51% relative risk reduction), a sample size of 182 will be used to have a power of 80% and a confidence interval of 95%.

  Eligibility

Ages Eligible for Study:   up to 1 Hour
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Estimated gestational age 29-36 6/7weeks or birth weight 1,400-2500g
  • Delivery in the hospital

Exclusion Criteria:

  • Infant admitted to the NICU
  • Birth weight less than 1,400g
  • 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: NCT01604317

Contacts
Contact: Waldemar A Carlo, MD 205-934-4680 wcarlo@peds.uab.edu
Contact: Theodore C Belsches, MS4 334-798-1544 tcb7@uab.edu

Locations
Zambia
University Teaching Hospital Recruiting
Lusaka, Zambia
Contact: Elwyn Chomba, MD       echomba@zamnet.zm   
Sub-Investigator: Theodore C Belsches, MS4         
Sub-Investigator: Rohan Kambeyanda, MS4         
Sub-Investigator: Tonya R Miller, MS4         
Sub-Investigator: Alyssa E Tilly, MS4         
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

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01604317     History of Changes
Other Study ID Numbers: UAB Neo 005
Study First Received: May 21, 2012
Last Updated: May 30, 2014
Health Authority: United States: Institutional Review Board
Zambia: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 27, 2014