University Teaching Hospital
Lusaka, Zambia
NCT Number: NCT01604447
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 V is comparing use of a plastic torso wrap to no plastic torso wrap in preterm/low birth weight infants following removal from their incubator to assist with temperature regulation.
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Notify Me1 hour–72 hour
All sexes
Interventional
Phase 4
Lusaka, Zambia
Due to limited resources and numbers of incubators, hospitals in developing countries remove infants from incubators at lower weights than in developed countries, putting infants at increased risk for hypothermia. This study will compare the incidence of hypothermia during the 72 hours after incubator removal of infants randomized to receive standard incubator removal (control group) or standard incubator removal with a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken upon removal from the incubator, every subsequent 6-8 hours, and finally, at 72 hours as the bags are removed. Blood pressure, blood sugar, seizures, weight gain, hyperthermia, death, observation for respiratory distress, bronchopulmonary dysplasia, sepsis, intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, intestinal perforation, pulmonary hemorrhage room temperature and humidity, and length of time in an incubator will be recorded throughout their hospitalization for all infants. With an estimated hypothermia incidence of 30% and a hypothesized 20% absolute risk reduction (66% relative risk reduction), a sample size of 118 will be used to have a power of 80% and a confidence interval of 95%.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Upon removal from the 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 and receive a cloth hat. The bag will be changed when soiled and the infant will remain in the bag for 72 hours or until discharge, whichever comes first. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.
Upon removal from incubator, the infant will be wrapped in a blanket and receive a cloth hat, according to standard bundling practices. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.
Time frame: 1-72 hours
Temperature taken per axilla for one minute
Time frame: Up to 4 weeks
Measure of extremity blood pressure per cuff taken during nursery stay
Time frame: Up to 4 weeks
Measure of blood glucose per laboratory value taken per heel stick
Time frame: Up to 4 weeks
Seizure activity diagnosed by medical doctor or nurse. No electoencephalogram will be done.
Time frame: Up to 4 weeks
Infant will be weighed daily and rates of weight gain will be calculated
Time frame: Up to 4 weeks
Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant
Time frame: 28 days after birth
Oxygen requirement at 28 days of life
Time frame: Up to 4 weeks
Either chest radiograph documentation or clinical deterioration consistent with air leak
Time frame: Up to 4 weeks
Culture proven or culture negative clinically treated course consistent with sepsis
Time frame: Up to 4 weeks
Intracranial hemorrhage grade 3-4 or periventricular leukomalacia documented on cranial ultrasound
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.
Time frame: Up to 4 weeks
Blood seen in the endotracheal tube and treated by physician
Time frame: Up to 4 weeks
Cardiorespiratory failure
Time frame: Up to 4 weeks
Axillary temperature > 38 degrees Celsius per temperature taken per axilla for 1 minute
Time frame: Up to 4 weeks
Documentation of length of time spent in incubator and number of times placed in incubator
Time frame: 1-72 hours
A recording of the room temperature and humidity will be obtained with each axillary temperature measurement
Time frame: 1 hour
A recording of the air temperature and humidity with the incubator will be obtained with each axillary temperature measurement
University of Alabama at Birmingham
Other
Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part IV
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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