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

The University of Alabama at Birmingham

Status and phase: Completed; Phase 4

Conditions: Hypothermia, Newborn

Treatments: Procedure: Resuscitation- no plastic bag for temperature regulation; Procedure: Resuscitation and post resuscitation care with plastic bag

Study type: Interventional

Funder types: Other

Identifiers

NCT01403623

UAB Neo 003

Details and patient eligibility

About

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).

Full 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.

Enrollment: 106 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Estimated gestational age 26-36.6 weeks or expected birth weight 1000-2500 grams.
• Delivery in the hospital.

Exclusion criteria

• Abdominal wall defect or myelomeningocele.
• Major congenital anomaly.
• Blistering skin disorder.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Resuscitation with plastic bag

Active Comparator group

Description:

Plastic bag will be used during and after resuscitation to assist with temperature regulation.

Treatment:

Procedure: Resuscitation and post resuscitation care with plastic bag

Standard resuscitation- no plastic bag

Sham Comparator group

Description:

Infant will be resuscitated per standard of care without being placed in a plastic bag for temperature regulation.

Treatment:

Procedure: Resuscitation- no plastic bag for temperature regulation