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

• Seizure [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: No ]
  Seizure activity diagnosed by medical director or nurse. No electroencephalogram will be done.
• 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
• 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
• 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 enterocolitis per Bell's Classification stage greater than 1.
• 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
• Temperature and humidity [ Time Frame: 1-72 hours after birth ] [ Designated as safety issue: No ]
  A recording of the room temperature and humidity will be obtained with each axillary temperature measurement

• Blood pressure [ Time Frame: Up to 4 weeks ] [ Designated as safety issue: Yes ]
  Measurement 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: No ]
  Seizure activity diagnosed by medical director 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) [ 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 of life
• 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 enterocolitis 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 an incubator
• Temperature and humidity [ Time Frame: 1-72 hours after birth ] [ Designated as safety issue: No ]
  A recording of the room temperature and humidity will be obtained with each axillary temperature measurement
• 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

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 II is for preterm/low birth weight infant with or without plastic head cover used from 1 hour after birth until discharge or 24 hours after birth to assist with temperature regulation.

Due to limited resources, hospitals in the developing world struggle to provide sufficient incubators and to maintain climate-controlled nurseries. Therefore, premature low birth weight infants continue to be at an increased risk of hypothermia throughout their hospitalizations. This study will compare the incidence of hypothermia in preterm/low birth weight infants randomized to receive WHO thermoregulation care (control groups) or WHO thermoregulation care and a plastic bag covering their torsos and lower extremities (intervention group) starting at one hour after birth and continued to discharge or 24 hours after birth, whichever occurs first. The axillary temperature of each infant will be taken one hour after birth, every subsequent 3-4 hours, and at discharge or 24 hours after birth when infants will be removed from the plastic bags. Seizures, hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 50% and a hypothesized 20% absolute risk reduction (40% relative risk reduction), a sample size of 182 will be used to have a power of 80% and a confidence interval of 95%.

• Procedure: Thermoregulation without plastic bag
  One hour after birth, a blanket will be wrapped around the infant and he/she will receive a wool hat, according to standard practices. The infant's axillary temperature will be monitored for 24 hours or until discharge, whichever comes first.
• Procedure: Thermoregulation with torso-covering plastic bag
  One hour after birth, the infant will be placed into a plastic bag up 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. A blanket will be wrapped around the infant, and he/she will receive a wool hat. The infant will remain in the bag, which will be changed when soiled, for 24 hours or until discharge, whichever occurs first.

• Sham Comparator: Thermoregulation-standard care
  Standard thermoregulation without a plastic bag from one hour after birth until discharge or 24 hours after birth, whichever comes first.
  Intervention: Procedure: Thermoregulation without plastic bag
• Active Comparator: Thermoregulation-torso bag
  Thermoregulation with plastic bag covering torso and lower extremities from one hour after birth until discharge or 24 hours after birth to assist with thermoregulation. The infant's axillary temperature will be monitored for 24 hours or until discharge, whichever comes first.
  Intervention: Procedure: Thermoregulation with torso-covering plastic bag

Inclusion Criteria:

• Estimated gestational age 29-36 6/7 weeks or birth weight 1400-2500g
• Delivery in the hospital

Exclusion Criteria:

• Infant admitted to the NICU
• Birth weight less than 1400 gms
• Abdominal wall defect or myelomeningocele
• Major congenital anomalies
• Blistering skin disorder