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

University of Alabama at Birmingham

Overview

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 III is for preterm/low birth weight infants with or without a plastic torso wrap during the first hour after birth to assist with temperature regulation during placement in an incubator.

Incubators in the developing world often lack humidifiers. The resting dry heat increases evaporative heat loss, the most prominent form of heat loss in premature infants due to their increased body surface area and immature stratum corneum. By potentially increasing humidity around the infants and decreasing evaporative heat losses, plastic bags may improve incubator warming. This study will compare the incidence of hypothermia in infants placed in an incubator for at least one hour randomized to receive standard incubator protocol (control group) or standard incubator protocol plus a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken before placement into the incubator and one hour later when the bag will be removed. Blood pressure, blood sugar, seizures, weight gain, hyperthermia, death, observation for respiratory distress syndrome, bronchopulmonary dysplasia, pneumothorax, sepsis, intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, intestinal perforation, pulmonary hemorrhage, incubator temperature, and humidity, and length of time in an incubator will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 90% and a hypothesized 20% absolute risk reduction (22% relative risk reduction), a sample size of 118 will be used to have a power of 80% and a confidence interval of 95%.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Hypothermia

Interventions

Incubator-torso bagPROCEDURE

While being placed into an incubator, infant will be placed into a plastic bag to his/her axillae and the bag will be folded and taped to itself to prevent it from covering the infant's nose or mouth. The infant will be wrapped in a blanket over the plastic bag and will receive a cloth hat. He/she will remain in the bag for one hour.

Incubator-no plastic bagPROCEDURE

Infant will be placed in the incubator, wrapped in a blanket, with a cloth hat, according to standard protocol.

Eligibility

Sex: ALLMin age: 1 MinuteMax age: 72 Hours

Medical Language ↔ Plain English

Inclusion Criteria: * Infant admitted to the NICU * Current weight between 1,000 and 2,500g * Being placed in an incubator Exclusion Criteria: * Abdominal wall defect or myelomeningocele * Major congenital anomalies * Blistering skin disorder

Locations (1)

University Teaching Hospital

Lusaka, Zambia

Outcomes

Primary Outcomes

Axillary temperature 36.5-37.5 degrees Celsius

Temperature taken per axilla for 1 minute

Time frame: 1-72 hours

Secondary Outcomes

Blood Pressure

Measure of extremity blood pressure per cuff taken during nursery stay

Time frame: Up to 4 weeks

Blood glucose

Measure of blood glucose per laboratory value taken per heel stick

Time frame: Up to 4 weeks

Seizure

Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done.

Time frame: Up to 4 weeks

Weight gain

Infant will be weighed daily and rates of weight gain will be calculated

Time frame: Up to 4 weeks

Respiratory Distress Syndrome (RDS) Respiratory Distress Syndrome (RDS)

Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant

Time frame: Up to 4 weeks

Bronchopulmonary dysplasia (BPD)

Oxygen requirement at 28 days after birth

Time frame: 28 days after birth

Pneumothorax

Either chest radiograph documentation or clinical deterioration consistent with air leak

Time frame: Up to 4 weeks

Data from ClinicalTrials.gov

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