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

The University of Alabama at Birmingham

Status and phase: Completed; Phase 4

Conditions: Newborn; Hypothermia

Treatments: Procedure: Resuscitation-no plastic bag; Procedure: Resuscitation with torso plastic bag

Study type: Interventional

Funder types: Other

Identifiers

NCT01604460

UAB Neo 010

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 V is comparing standard WHO thermoregulation practices plus use of a plastic torso wrap to no plastic torso wrap in full term infants from resuscitation to one hour after birth.

Full description

Due to delivery rooms without adequate climate controls, even full term infants have high rates of hypothermia in the developing world. This study will compare the rates of hypothermia one hour after birth in full term infants randomized to receive standard WHO thermoregulation care (control group) or standard WHO thermoregulation care without immediate drying plus a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken within 15 minutes of birth at at one hour after birth with removal of the plastic bag. Hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 15% and a hypothesized 10% absolute risk reduction (66% relative risk reduction), a sample size of 276 will be used to have a power of 80% and a confidence interval of 95%.

Enrollment: 275 patients

Sex: All

Ages: 1 minute to 72 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Estimated gestational age 37 weeks and greater
• Birth weight greater than 2,500gms
• Delivery in the hospital

Exclusion criteria

• Infant admitted to the NICU
• Birth weight less than 2,500gms
• 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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275 participants in 2 patient groups

Resuscitation-no plastic bag

Sham Comparator group

Description:

Resuscitation per standard of care without a plastic bag

Treatment:

Procedure: Resuscitation-no plastic bag

Resuscitation-torso bag

Active Comparator group

Description:

Use of plastic bag covering the torso and lower extremities for temperature regulation during and after resuscitation for the first hour after birth

Treatment:

Procedure: Resuscitation with torso plastic bag