Clinical trial NCT01604434: Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part III
Official title: Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part III
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypothermia
Keywords: Hypothermia
Low birth Weight
Newborn
Incubator
Plastic bag
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Children's Health System, Alabama
First posted: 2012-05-23
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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%.

Eligibility criteria: 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

Primary outcomes:
measure: Axillary temperature 36.5-37.5 degrees Celsius
timeFrame: 1-72 hours
Secondary outcomes:
measure: Blood Pressure
timeFrame: Up to 4 weeks
measure: Blood glucose
timeFrame: Up to 4 weeks
measure: Seizure
timeFrame: Up to 4 weeks
measure: Weight gain
timeFrame: Up to 4 weeks
measure: Respiratory Distress Syndrome (RDS) Respiratory Distress Syndrome (RDS)
timeFrame: Up to 4 weeks
measure: Bronchopulmonary dysplasia (BPD)
timeFrame: 28 days after birth
measure: Pneumothorax
timeFrame: Up to 4 weeks
measure: Sepsis
timeFrame: Up to 4 weeks
measure: Major brain injury
timeFrame: Up to 4 weeks
measure: Necrotizing enterocolitis or intestinal perforation
timeFrame: Up to 4 weeks
measure: Pulmonary hemorrhage
timeFrame: Up to 4 weeks
measure: Death
timeFrame: Up to 4 weeks
measure: Hyperthermia
timeFrame: Up to 4 weeks
measure: Length of time in Incubator
timeFrame: Up to 4 weeks
measure: Temperature and humidity
timeFrame: 1 hour
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: University Teaching Hospital
Study officials:
affiliation: University of Alabama at Birmingham
name: Waldemar A Carlo, MD
role: PRINCIPAL_INVESTIGATOR
References: