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

The University of Alabama at Birmingham

Status and phase: Completed; Phase 4

Conditions: Hypothermia

Treatments: Procedure: Hypothermia prevention without plastic bag; Procedure: Hypothermia prevention with plastic bag

Study type: Interventional

Funder types: Other

Identifiers

NCT01604447

UAB Neo 009

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 use of a plastic torso wrap to no plastic torso wrap in preterm/low birth weight infants following removal from their incubator to assist with temperature regulation.

Full description

Due to limited resources and numbers of incubators, hospitals in developing countries remove infants from incubators at lower weights than in developed countries, putting infants at increased risk for hypothermia. This study will compare the incidence of hypothermia during the 72 hours after incubator removal of infants randomized to receive standard incubator removal (control group) or standard incubator removal with a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken upon removal from the incubator, every subsequent 6-8 hours, and finally, at 72 hours as the bags are removed. Blood pressure, blood sugar, seizures, weight gain, hyperthermia, death, observation for respiratory distress, bronchopulmonary dysplasia, sepsis, intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, intestinal perforation, pulmonary hemorrhage room temperature and humidity, and length of time in an incubator will be recorded throughout their hospitalization for all infants. With an estimated hypothermia incidence of 30% and a hypothesized 20% absolute risk reduction (66% relative risk reduction), a sample size of 118 will be used to have a power of 80% and a confidence interval of 95%.

Enrollment: 118 patients

Sex: All

Ages: 1 to 72 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infant admitted to the NICU
• Current weight less than 2,000g
• Being removed from incubator

Exclusion criteria

• 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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118 participants in 2 patient groups, including a placebo group

Incubator removal-torso bag

Active Comparator group

Description:

Use plastic bag covering the torso and lower extremities for temperature regulation with standard bundling practices when removing infant from incubator

Treatment:

Procedure: Hypothermia prevention with plastic bag

Incubator removal-no plastic bag

Placebo Comparator group

Description:

Standard bundling practices when removing the infant from the incubator. No plastic bag used.

Treatment:

Procedure: Hypothermia prevention without plastic bag