Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part III
- Conditions
- Hypothermia
- Interventions
- Procedure: Incubator-no plastic bagProcedure: Incubator-torso bag
- Registration Number
- NCT01604434
- Lead Sponsor
- University of Alabama at Birmingham
- 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 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.
- Detailed Description
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%.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Infant admitted to the NICU
- Current weight between 1,000 and 2,500g
- Being placed in an incubator
- Abdominal wall defect or myelomeningocele
- Major congenital anomalies
- Blistering skin disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Incubator-no plastic bag Incubator-no plastic bag Placement into an incubator without a plastic bag Incubator-torso bag Incubator-torso bag Placement into a plastic bag inside incubator
- Primary Outcome Measures
Name Time Method Axillary temperature 36.5-37.5 degrees Celsius 1-72 hours Temperature taken per axilla for 1 minute
- Secondary Outcome Measures
Name Time Method Blood Pressure Up to 4 weeks Measure of extremity blood pressure per cuff taken during nursery stay
Seizure Up to 4 weeks Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.
Weight gain Up to 4 weeks Infant will be weighed daily and rates of weight gain will be calculated
Blood glucose Up to 4 weeks Measure of blood glucose per laboratory value taken per heel stick
Respiratory Distress Syndrome (RDS) Respiratory Distress Syndrome (RDS) Up to 4 weeks Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant
Bronchopulmonary dysplasia (BPD) 28 days after birth Oxygen requirement at 28 days after birth
Pneumothorax Up to 4 weeks Either chest radiograph documentation or clinical deterioration consistent with air leak
Sepsis Up to 4 weeks Culture proven or culture negative clinically treated course consistent with sepsis
Major brain injury Up to 4 weeks Intracranial hemorrhage grade 3-4 or periventricular leukomalacia documented on cranial ultrasound
Necrotizing enterocolitis or intestinal perforation Up to 4 weeks 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 Up to 4 weeks Blood seen in the endotracheal tube and treated by physician
Death Up to 4 weeks Cardiorespiratory failure
Hyperthermia Up to 4 weeks Axillary temperature \> 38 degrees Celsius per temperature taken per axilla for one minute
Length of time in Incubator Up to 4 weeks Documentation of length of time spent in incubator and number of times placed in incubator
Temperature and humidity 1 hour A recording of the air temperature and humidity within the incubator will be obtained with each axillary temperature measurement
Trial Locations
- Locations (1)
University Teaching Hospital
🇿🇲Lusaka, Zambia