NCT01403623

Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates

A Randomized Trial to Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates in Developing Countries

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Hypothermia, Newborn

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-03-01
• Completion: 2012-12-01
• First posted: 2011-07-27
• Last updated: 2013-08-21

Locations

1 site across 1 country: Zambia