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

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:
NCT01604421
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 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.


Condition Intervention Phase
Hypothermia
Procedure: Thermoregulation without plastic bag
Procedure: Thermoregulation with torso-covering 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 II

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: Discharge or 24 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 as severe hypothermia.


Secondary Outcome Measures:
  • Seizure [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
    Seizure activity diagnosed by medical director 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 1.

  • 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: February 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Thermoregulation-standard care
Standard thermoregulation without a plastic bag from one hour after birth until discharge or 24 hours after birth, whichever comes first.
Procedure: Thermoregulation 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.
Active Comparator: Thermoregulation-torso 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.
Procedure: Thermoregulation with torso-covering 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.

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%.

  Eligibility

Ages Eligible for Study:   up to 120 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01604421

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: NCT01604421     History of Changes
Other Study ID Numbers: UAB Neo 007
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
Plastic bag
Thermoregulation

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

ClinicalTrials.gov processed this record on July 26, 2014