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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part IV

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.

Detailed Summary: 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%.
Sponsor: University of Alabama at Birmingham

Current Primary Outcome: Axillary temperature 36.5-37.5 degrees Celsius [ Time Frame: 1-72 hours ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Blood pressure [ Time Frame: Up to 4 weeks ]
  Measure of extremity blood pressure per cuff taken during nursery stay
• Blood glucose [ Time Frame: Up to 4 weeks ]
  Measure of blood glucose per laboratory value taken per heel stick
• Seizure [ Time Frame: Up to 4 weeks ]
  Seizure activity diagnosed by medical doctor or nurse. No electoencephalogram will be done.
• Weight gain [ Time Frame: Up to 4 weeks ]
  Infant will be weighed daily and rates of weight gain will be calculated
• 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
• Bronchopulmonary Dysplasia (BPD) [ Time Frame: 28 days after birth ]
  Oxygen requirement at 28 days of life
• Pneumothorax [ Time Frame: Up to 4 weeks ]
  Either chest radiograph documentation or clinical deterioration consistent with air leak
• Sepsis [ Time Frame: Up to 4 weeks ]
  Culture proven or culture negative clinically treated course consistent with sepsis
• Major brain injury [ Time Frame: Up to 4 weeks ]
  Intracranial hemorrhage grade 3-4 or periventricular leukomalacia documented on cranial ultrasound
• 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.
• Pulmonary hemorrhage [ Time Frame: Up to 4 weeks ]
  Blood seen in the endotracheal tube and treated by physician
• Death [ Time Frame: Up to 4 weeks ]
  Cardiorespiratory failure
• Hyperthermia [ Time Frame: Up to 4 weeks ]
  Axillary temperature > 38 degrees Celsius per temperature taken per axilla for 1 minute
• 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
• 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
• 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

Original Secondary Outcome: Same as current

Information By: University of Alabama at Birmingham

Dates:
Date Received: May 21, 2012
Date Started: June 2012
Date Completion:
Last Updated: February 23, 2015
Last Verified: February 2015