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

• Axillary temperature 36.5-37.5 degrees Celsius [ Time Frame: 1-72 hours ] [ Designated as safety issue: Yes ]
  Temperature taken per axilla for 1 minute
  
  

• Blood Pressure [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
  Measure of extremity blood pressure per cuff taken during nursery stay
  
  
• Blood glucose [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
  Measure of blood glucose per laboratory value taken per heel stick
  
  
• Seizure [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
  Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.
  
  
• Weight gain [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
  Infant will be weighed daily and rates of weight gain will be calculated
  
  
• Respiratory Distress Syndrome (RDS) 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
  
  
• Bronchopulmonary dysplasia (BPD) [ Time Frame: 28 days after birth ] [ Designated as safety issue: Yes ]
  Oxygen requirement at 28 days after birth
  
  
• 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
  
  
• Major brain injury [ Time Frame: Up to 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: Up to 4 weeks ] [ Designated as safety issue: Yes ]
  Documentation of pneumatosis or intestinal perforation on x-ray or treatment course for clinical necrotizing enterocoliities per Bell's Classification stage greater than 1.
  
  
• Pulmonary hemorrhage [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
  Blood seen in the endotracheal tube and treated by physician
  
  
• 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
  
  
• Length of time in Incubator [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
  Documentation of length of time spent in incubator and number of times placed in incubator
  
  
• Temperature and humidity [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
  A recording of the air temperature and humidity within the incubator will be obtained with each axillary temperature measurement
  
  

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%.