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

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ClinicalTrials.gov Identifier: NCT01604447
Recruitment Status : Completed
First Posted : May 23, 2012
Last Update Posted : February 24, 2015
Sponsor:
Collaborator:
Children's of Alabama
Information provided by (Responsible Party):
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 V is comparing use of a plastic torso wrap to no plastic torso wrap in preterm/low birth weight infants following removal from their incubator to assist with temperature regulation.

Condition or disease Intervention/treatment Phase
Hypothermia Procedure: Hypothermia prevention with plastic bag Procedure: Hypothermia prevention without plastic bag Phase 4

Detailed Description:
Due to limited resources and numbers of incubators, hospitals in developing countries remove infants from incubators at lower weights than in developed countries, putting infants at increased risk for hypothermia. This study will compare the incidence of hypothermia during the 72 hours after incubator removal of infants randomized to receive standard incubator removal (control group) or standard incubator removal with a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken upon removal from the incubator, every subsequent 6-8 hours, and finally, at 72 hours as the bags are removed. Blood pressure, blood sugar, seizures, weight gain, hyperthermia, death, observation for respiratory distress, bronchopulmonary dysplasia, sepsis, intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, intestinal perforation, pulmonary hemorrhage room temperature and humidity, and length of time in an incubator will be recorded throughout their hospitalization for all infants. With an estimated hypothermia incidence of 30% and a hypothesized 20% absolute risk reduction (66% 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)
Actual 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 IV
Study Start Date : June 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
Active Comparator: Incubator removal-torso bag
Use plastic bag covering the torso and lower extremities for temperature regulation with standard bundling practices when removing infant from incubator
Procedure: Hypothermia prevention with plastic bag
Upon removal from the 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 and receive a cloth hat. The bag will be changed when soiled and the infant will remain in the bag for 72 hours or until discharge, whichever comes first. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.

Placebo Comparator: Incubator removal-no plastic bag
Standard bundling practices when removing the infant from the incubator. No plastic bag used.
Procedure: Hypothermia prevention without plastic bag
Upon removal from incubator, the infant will be wrapped in a blanket and receive a cloth hat, according to standard bundling practices. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.




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

  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 enterocolitis 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 1 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. Room temperature and humidity [ Time Frame: 1-72 hours ]
    A recording of the room temperature and humidity will be obtained with each axillary temperature measurement

  16. Incubator temperature and humidity [ Time Frame: 1 hour ]
    A recording of the air temperature and humidity with 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
Criteria

Inclusion Criteria:

  • Infant admitted to the NICU
  • Current weight less than 2,000g
  • Being removed from 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 ClinicalTrials.gov identifier (NCT number): NCT01604447


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

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01604447     History of Changes
Other Study ID Numbers: UAB Neo 009
First Posted: May 23, 2012    Key Record Dates
Last Update Posted: February 24, 2015
Last Verified: February 2015

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

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