Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part I

The University of Alabama at Birmingham

Status: Active, not recruiting

Conditions: Immature Newborn; Hypothermia

Treatments: Procedure: Resuscitation-torso plastic bag; Procedure: Resuscitation-partial-head plastic bag

Study type: Interventional

Funder types: Other

Identifiers

NCT01604317

Caduceus Club (Other Identifier)

UAB Neo 005

Perinatal Health/Human (Other Identifier)

Childrens Centennial (Other Identifier)

Details and patient eligibility

About

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 I is for preterm/low birth weight infant with or without plastic head cover used during resuscitation.

Full description

This study will compare the incidence of hypothermia during the first hour after birth in preterm/low birth weight infants randomized to receive WHO thermoregulation care and a plastic bag (without drying) covering the torso and lower extremities (control group) or WHO thermoregulation care and a plastic bag (without drying) covering the torso, upper and lower extremities, and a portion of their head (intervention group). The axillary temperature of each infant will be taken initially within 15 minutes of birth and later at 1 hour after birth as the infant is removed from the plastic bag. Seizures, hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 41% and a 21% absolute risk reduction (51% relative risk reduction), a sample size of 182 will be used to have a power of 80% and a confidence interval of 95%.

Enrollment: 182 patients

Sex: All

Ages: 1 minute to 1 hour old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Estimated gestational age 29-36 6/7weeks or birth weight 1,400-2500g
• Delivery in the hospital

Exclusion criteria

• Infant admitted to the NICU
• Birth weight less than 1,400g
• Abdominal wall defect or myelomeningocele
• Major congenital anomalies
• Blistering skin disorder

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups

Resuscitation-torso plastic bag

Active Comparator group

Description:

Resuscitation with plastic bag covering torso and lower extremities for first hour to assist with temperature regulation.

Treatment:

Procedure: Resuscitation-torso plastic bag

Resuscitation-partial-head plastic bag

Active Comparator group

Description:

Resuscitation with plastic bag covering torso, upper and lower extremities, and a portion of the head for first hour after birth to assist with temperature regulation.

Treatment:

Procedure: Resuscitation-partial-head plastic bag