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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 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.

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

Current Primary Outcome: Axillary temperature < 36.5 degrees Celsius [ Time Frame: Discharge or 24 hours after birth ]

Original Primary Outcome: Axillary temperature 36.5-37.5 degrees Celsius [ Time Frame: Discharge or 24 hours after birth ]

Current Secondary Outcome:

• Seizure [ Time Frame: Up to 4 weeks ]
  Seizure activity diagnosed by medical director or nurse. No electroencephalogram will be done.
• 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
• 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
• 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.
• 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 one minute
• Temperature and humidity [ Time Frame: 1-72 hours after birth ]
  A recording of the room temperature and humidity will be obtained with each axillary temperature measurement

Original Secondary Outcome:

• Blood pressure [ Time Frame: Up to 4 weeks ]
  Measurement 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 director or nurse. No electroencephalogram 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 one 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 an incubator
• Temperature and humidity [ Time Frame: 1-72 hours after birth ]
  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 within the incubator will be obtained with each axillary temperature measurement

Information By: University of Alabama at Birmingham

Dates:
Date Received: May 21, 2012
Date Started: February 2013
Date Completion: October 2017
Last Updated: April 4, 2017
Last Verified: August 2016