Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates
NCT ID: NCT01403623
Last Updated: 2013-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
106 participants
INTERVENTIONAL
2011-08-31
2012-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Resuscitation with plastic bag
Plastic bag will be used during and after resuscitation to assist with temperature regulation.
Resuscitation and post resuscitation care with plastic bag
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.
Standard resuscitation- no plastic bag
Infant will be resuscitated per standard of care without being placed in a plastic bag for temperature regulation.
Resuscitation- no plastic bag for temperature regulation
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.
Interventions
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Resuscitation and post resuscitation care with plastic bag
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.
Resuscitation- no plastic bag for temperature regulation
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.
Eligibility Criteria
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Inclusion Criteria
* Delivery in the hospital.
Exclusion Criteria
* Major congenital anomaly.
* Blistering skin disorder.
ALL
No
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Alicia Leadford, MD
Fellow Instructor, Department of Pediatrics, Division of Neonatology
Principal Investigators
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Waldemar A Carlo, MD
Role: STUDY_DIRECTOR
University of Alabama at Birmingham
Alicia E Leadford, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University Teaching Hospital
Lusaka, , Zambia
Countries
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References
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Leadford AE, Warren JB, Manasyan A, Chomba E, Salas AA, Schelonka R, Carlo WA. Plastic bags for prevention of hypothermia in preterm and low birth weight infants. Pediatrics. 2013 Jul;132(1):e128-34. doi: 10.1542/peds.2012-2030. Epub 2013 Jun 3.
Other Identifiers
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UAB Neo 003
Identifier Type: -
Identifier Source: org_study_id