Clinical trial NCT01604447: Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part IV
Official title: Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part IV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypothermia
Keywords: Hypothermia
Newborn
Incubator
Plastic bag
Normothermia
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Children's of Alabama
First posted: 2012-05-23
Enrollment: 118
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 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.

Detailed 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%.

Eligibility criteria: 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

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)
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: Room temperature and humidity
timeFrame: 1-72 hours
measure: Incubator 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: