Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part III
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 III is for preterm/low birth weight infants with or without a plastic torso wrap during the first hour after birth to assist with temperature regulation during placement in an incubator.
Procedure: Incubator-torso bag
Procedure: Incubator-no plastic bag
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-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
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||February 2017|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Sham Comparator: Incubator-no plastic bag
Placement into an incubator without a plastic bag
Procedure: Incubator-no plastic bag
Infant will be placed in the incubator, wrapped in a blanket, with a cloth hat, according to standard protocol.
Active Comparator: Incubator-torso bag
Placement into a plastic bag inside incubator
Procedure: Incubator-torso bag
While being placed into an 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 over the plastic bag and will receive a cloth hat. He/she will remain in the bag for one hour.
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%.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604434
|Contact: Waldemar A Carlo, MDfirstname.lastname@example.org|
|Contact: Theodore C Belsches, MS4email@example.com|
|University Teaching Hospital||Recruiting|
|Contact: Elwyn Chomba, MD firstname.lastname@example.org|
|Sub-Investigator: Theodore C Belsches, MS4|
|Sub-Investigator: Rohan Kambeyanda, MS4|
|Sub-Investigator: Tonya R Miller, MS4|
|Sub-Investigator: Alyssa E Tilly, MS4|
|Principal Investigator:||Waldemar A Carlo, MD||University of Alabama at Birmingham|