University Teaching Hospital
Lusaka, Zambia
NCT Number: NCT01403623
The overall hypothesis is that placing infants 1000-2500 grams in plastic bags when compared to routine care will reduce the risk of hypothermia (< 36.5 degrees C) without increasing hyperthermia (> 37.5 degrees C).
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Interventional
Phase 4
Lusaka, Zambia
Prevention
After consent, infants with estimated gestational age between 26-36.6 weeks or with expected birth weight 1000-2500 grams will be randomized to resuscitation per standard protocol or to resuscitation per standard protocol and plastic bag. The intervention group will be placed into a plastic bag covering the body and back and top of head (excluding face) prior to drying the body's surface. Resuscitation efforts continue per standard of care. The infant will remain in the bag through the admission process until his/her axillary temp is in the range of 36.5- 37.5 degrees Celsius. At this time, the bag will be discontinued and discarded. Standard temperature control will be continued per nursery standard. Skin-to-skin contact between mother and baby is not excluded; however, the infant will remain in the plastic bag. Infant's axillary temperature will be measured per nursery standard after discontinuation of plastic bag. The control group will receive standard of care thermoregulation. Secondary measures (i.e. blood pressures, glucose levels, weight gain, observation for respiratory distress syndrome, bronchopulmonary dysplasia, pneumothorax, sepsis, seizures, intraventricular hemorrhage, necrotizing enterocolitis, pulmonary hemorrhage, and death) will be recorded in both groups.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Infant will be resuscitated and placed in a plastic bag up to his/her neck and around the back of his head (not covering the face) in the delivery room and taken to the nursery. The infant will remain in the plastic bag until first axillary temperature remains stable at 36.5-37.5 degrees Celsius. Expected length of time approximately one hour.
Infant will be resuscitated in the delivery room and taken to the nursery. The infant will be observed per unit standard until first axillary temperature remains stable at 36.5-37.5 degrees Celsius. Expected length of time approximately one hour.
Time frame: 1-4 hours
Temperature taken per axilla for 1 minute
Time frame: Duration of hospitalization-expected average of 4 weeks
Measure of extremity blood pressure per cuff taken during nursery stay.
Time frame: Duration of hospitalization-expected average of 4 weeks
Measure of blood glucose per laboratory value taken per heelstick
Time frame: Duration of hospitalization-expected average of 4 weeks
Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.
Time frame: Duration of hospitalization-expected average of 4 weeks
Infant will be weighed daily and rates of weight gain will be measured.
Time frame: Duration of hospitalization-expected average of 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: Duration of hospitalization-expected average of 4 weeks
Either chest radiograph documentation or clinical deterioration consistent with air leak
Time frame: Duration of hospitalization-expected average of 4 weeks
Culture proven or culture negative clinically treated course consistent with sepsis.
Time frame: Duration of hospitalization-expected average of 4 weeks
Intracranial hemorrhage Grade 3-4 or periventricular leukomalacia documented on cranial ultrasound
Time frame: Duration of hospitalization-expected average of 4 weeks
Documentation of pneumatosis or intestinal perforation on x ray or treatment course for clinical necrotizing enterocolitis per Bell's stage greater than one.
Time frame: Duration of hospitalization-expected average of 4 weeks
Blood seen in the endotracheal tube and treated by physician.
Time frame: Duration of hospitalization-expected average of 4 weeks
Cardiorespiratory failure
University of Alabama at Birmingham
Other
A Randomized Trial to Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates in Developing Countries
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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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