Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alicia Leadford, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01403623
First received: June 27, 2011
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

The overall hypothesis is that placing infants 1000-2500 grams in plastic bags when compared to routine care will reduce the risk of hypothermia (< 36.5 degrees C) without increasing hyperthermia (> 37.5 degrees C).


Condition Intervention Phase
Hypothermia, Newborn
Procedure: Resuscitation and post resuscitation care with plastic bag
Procedure: Resuscitation- no plastic bag for temperature regulation
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: A Randomized Trial to Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates in Developing Countries

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Axillary temperature 36.5-37.5 degrees Celsius [ Time Frame: 1-4 hours ] [ Designated as safety issue: Yes ]
    Temperature taken per axilla for 1 minute


Secondary Outcome Measures:
  • Blood pressure [ Time Frame: Duration of hospitalization-expected average of 4 weeks ] [ Designated as safety issue: Yes ]
    Measure of extremity blood pressure per cuff taken during nursery stay.

  • Blood glucose [ Time Frame: Duration of hospitalization-expected average of 4 weeks ] [ Designated as safety issue: Yes ]
    Measure of blood glucose per laboratory value taken per heelstick

  • Seizure [ Time Frame: Duration of hospitalization-expected average of 4 weeks ] [ Designated as safety issue: Yes ]
    Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.

  • Weight gain [ Time Frame: Duration of hospitalization-expected average of 4 weeks ] [ Designated as safety issue: Yes ]
    Infant will be weighed daily and rates of weight gain will be measured.

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

  • Bronchopulmonary dysplasia (BPD) [ Time Frame: 28 days after birth ] [ Designated as safety issue: Yes ]
    Oxygen requirement at 28 days of life

  • Pneumothorax [ Time Frame: Duration of hospitalization-expected average of 4 weeks ] [ Designated as safety issue: Yes ]
    Either chest radiograph documentation or clinical deterioration consistent with air leak

  • Sepsis [ Time Frame: Duration of hospitalization-expected average of 4 weeks ] [ Designated as safety issue: Yes ]
    Culture proven or culture negative clinically treated course consistent with sepsis.

  • Major brain injury [ Time Frame: Duration of hospitalization-expected average of 4 weeks ] [ Designated as safety issue: Yes ]
    Intracranial hemorrhage Grade 3-4 or periventricular leukomalacia documented on cranial ultrasound

  • Necrotizing enterocolitis or intestinal perforation [ Time Frame: Duration of hospitalization-expected average of 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 stage greater than one.

  • Pulmonary hemorrhage [ Time Frame: Duration of hospitalization-expected average of 4 weeks ] [ Designated as safety issue: Yes ]
    Blood seen in the endotracheal tube and treated by physician.

  • Death [ Time Frame: Duration of hospitalization-expected average of 4 weeks ] [ Designated as safety issue: Yes ]
    Cardiorespiratory failure


Enrollment: 106
Study Start Date: August 2011
Study Completion Date: December 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Resuscitation with plastic bag
Plastic bag will be used during and after resuscitation to assist with temperature regulation.
Procedure: Resuscitation and post resuscitation care with plastic bag
Infant will be resuscitated and placed in a plastic bag up to his/her neck and around the back of his head (not covering the face) in the delivery room and taken to the nursery. The infant will remain in the plastic bag until first axillary temperature remains stable at 36.5-37.5 degrees Celsius. Expected length of time approximately one hour.
Sham Comparator: Standard resuscitation- no plastic bag
Infant will be resuscitated per standard of care without being placed in a plastic bag for temperature regulation.
Procedure: Resuscitation- no plastic bag for temperature regulation
Infant will be resuscitated in the delivery room and taken to the nursery. The infant will be observed per unit standard until first axillary temperature remains stable at 36.5-37.5 degrees Celsius. Expected length of time approximately one hour.

Detailed Description:

Prevention

After consent, infants with estimated gestational age between 26-36.6 weeks or with expected birth weight 1000-2500 grams will be randomized to resuscitation per standard protocol or to resuscitation per standard protocol and plastic bag. The intervention group will be placed into a plastic bag covering the body and back and top of head (excluding face) prior to drying the body's surface. Resuscitation efforts continue per standard of care. The infant will remain in the bag through the admission process until his/her axillary temp is in the range of 36.5- 37.5 degrees Celsius. At this time, the bag will be discontinued and discarded. Standard temperature control will be continued per nursery standard. Skin-to-skin contact between mother and baby is not excluded; however, the infant will remain in the plastic bag. Infant's axillary temperature will be measured per nursery standard after discontinuation of plastic bag. The control group will receive standard of care thermoregulation. Secondary measures (i.e. blood pressures, glucose levels, weight gain, observation for respiratory distress syndrome, bronchopulmonary dysplasia, pneumothorax, sepsis, seizures, intraventricular hemorrhage, necrotizing enterocolitis, pulmonary hemorrhage, and death) will be recorded in both groups.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Estimated gestational age 26-36.6 weeks or expected birth weight 1000-2500 grams.
  • Delivery in the hospital.

Exclusion Criteria:

  • Abdominal wall defect or myelomeningocele.
  • Major congenital anomaly.
  • 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: NCT01403623

Locations
Zambia
University Teaching Hospital
Lusaka, Zambia
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Study Director: Waldemar A Carlo, MD University of Alabama at Birmingham
Principal Investigator: Alicia E Leadford, 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: Alicia Leadford, MD, Fellow Instructor, Department of Pediatrics, Division of Neonatology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01403623     History of Changes
Other Study ID Numbers: UAB Neo 003
Study First Received: June 27, 2011
Last Updated: August 19, 2013
Health Authority: United States: Institutional Review Board
Zambia: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 20, 2014