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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01604434
Recruitment Status : Recruiting
First Posted : May 23, 2012
Last Update Posted : November 22, 2017
Children's Health System, Alabama
Information provided by (Responsible Party):
Waldemar A. Carlo, MD, University of Alabama at Birmingham

Brief 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 III is for preterm/low birth weight infants with or without a plastic torso wrap during the first hour after birth to assist with temperature regulation during placement in an incubator.

Condition or disease Intervention/treatment Phase
Hypothermia Procedure: Incubator-torso bag Procedure: Incubator-no plastic bag Not Applicable

Detailed Description:
Incubators in the developing world often lack humidifiers. The resting dry heat increases evaporative heat loss, the most prominent form of heat loss in premature infants due to their increased body surface area and immature stratum corneum. By potentially increasing humidity around the infants and decreasing evaporative heat losses, plastic bags may improve incubator warming. This study will compare the incidence of hypothermia in infants placed in an incubator for at least one hour randomized to receive standard incubator protocol (control group) or standard incubator protocol plus a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken before placement into the incubator and one hour later when the bag will be removed. Blood pressure, blood sugar, seizures, weight gain, hyperthermia, death, observation for respiratory distress syndrome, bronchopulmonary dysplasia, pneumothorax, sepsis, intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, intestinal perforation, pulmonary hemorrhage, incubator temperature, and humidity, and length of time in an incubator will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 90% and a hypothesized 20% absolute risk reduction (22% relative risk reduction), a sample size of 118 will be used to have a power of 80% and a confidence interval of 95%.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part III
Study Start Date : June 2012
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
Sham Comparator: Incubator-no plastic bag
Placement into an incubator without a plastic bag
Procedure: Incubator-no plastic bag
Infant will be placed in the incubator, wrapped in a blanket, with a cloth hat, according to standard protocol.

Active Comparator: Incubator-torso bag
Placement into a plastic bag inside incubator
Procedure: Incubator-torso bag
While being placed into an incubator, infant will be placed 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. The infant will be wrapped in a blanket over the plastic bag and will receive a cloth hat. He/she will remain in the bag for one hour.

Primary Outcome Measures :
  1. Axillary temperature 36.5-37.5 degrees Celsius [ Time Frame: 1-72 hours ]
    Temperature taken per axilla for 1 minute

Secondary Outcome Measures :
  1. Blood Pressure [ Time Frame: Up to 4 weeks ]
    Measure of extremity blood pressure per cuff taken during nursery stay

  2. Blood glucose [ Time Frame: Up to 4 weeks ]
    Measure of blood glucose per laboratory value taken per heel stick

  3. Seizure [ Time Frame: Up to 4 weeks ]
    Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.

  4. Weight gain [ Time Frame: Up to 4 weeks ]
    Infant will be weighed daily and rates of weight gain will be calculated

  5. Respiratory Distress Syndrome (RDS) Respiratory Distress Syndrome (RDS) [ Time Frame: Up to 4 weeks ]
    Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant

  6. Bronchopulmonary dysplasia (BPD) [ Time Frame: 28 days after birth ]
    Oxygen requirement at 28 days after birth

  7. Pneumothorax [ Time Frame: Up to 4 weeks ]
    Either chest radiograph documentation or clinical deterioration consistent with air leak

  8. Sepsis [ Time Frame: Up to 4 weeks ]
    Culture proven or culture negative clinically treated course consistent with sepsis

  9. Major brain injury [ Time Frame: Up to 4 weeks ]
    Intracranial hemorrhage grade 3-4 or periventricular leukomalacia documented on cranial ultrasound

  10. Necrotizing enterocolitis or intestinal perforation [ Time Frame: Up to 4 weeks ]
    Documentation of pneumatosis or intestinal perforation on x-ray or treatment course for clinical necrotizing enterocoliities per Bell's Classification stage greater than 1.

  11. Pulmonary hemorrhage [ Time Frame: Up to 4 weeks ]
    Blood seen in the endotracheal tube and treated by physician

  12. Death [ Time Frame: Up to 4 weeks ]
    Cardiorespiratory failure

  13. Hyperthermia [ Time Frame: Up to 4 weeks ]
    Axillary temperature > 38 degrees Celsius per temperature taken per axilla for one minute

  14. Length of time in Incubator [ Time Frame: Up to 4 weeks ]
    Documentation of length of time spent in incubator and number of times placed in incubator

  15. Temperature and humidity [ Time Frame: 1 hour ]
    A recording of the air temperature and humidity within the incubator will be obtained with each axillary temperature measurement

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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Infant admitted to the NICU
  • Current weight between 1,000 and 2,500g
  • Being placed in an incubator

Exclusion Criteria:

  • Abdominal wall defect or myelomeningocele
  • Major congenital anomalies
  • Blistering skin disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01604434

Contact: Waldemar A Carlo, MD 205-934-4680
Contact: Theodore C Belsches, MS4 334-798-1544

University Teaching Hospital Recruiting
Lusaka, Zambia
Contact: Elwyn Chomba, MD   
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
Principal Investigator: Waldemar A Carlo, MD University of Alabama at Birmingham

Responsible Party: Waldemar A. Carlo, MD, Edwin M. Dixon Professor of Pediatrics, University of Alabama at Birmingham Identifier: NCT01604434     History of Changes
Other Study ID Numbers: UAB Neo 008
First Posted: May 23, 2012    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: November 2017

Keywords provided by Waldemar A. Carlo, MD, University of Alabama at Birmingham:
Low birth Weight
Plastic bag

Additional relevant MeSH terms:
Body Temperature Changes
Signs and Symptoms