Clinical trial NCT01604421: Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part II
Official title: Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part II
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypothermia
Keywords: Hypothermia
Low birth weight
Newborn
Plastic bag
Thermoregulation
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): 120
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 II is for preterm/low birth weight infant with or without plastic head cover used from 1 hour after birth until discharge or 24 hours after birth to assist with temperature regulation.

Detailed description: Due to limited resources, hospitals in the developing world struggle to provide sufficient incubators and to maintain climate-controlled nurseries. Therefore, premature low birth weight infants continue to be at an increased risk of hypothermia throughout their hospitalizations. This study will compare the incidence of hypothermia in preterm/low birth weight infants randomized to receive WHO thermoregulation care (control groups) or WHO thermoregulation care and a plastic bag covering their torsos and lower extremities (intervention group) starting at one hour after birth and continued to discharge or 24 hours after birth, whichever occurs first. The axillary temperature of each infant will be taken one hour after birth, every subsequent 3-4 hours, and at discharge or 24 hours after birth when infants will be removed from the plastic bags. Seizures, hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 50% and a hypothesized 20% absolute risk reduction (40% relative risk reduction), a sample size of 182 will be used to have a power of 80% and a confidence interval of 95%.

Eligibility criteria: Inclusion Criteria:

* Estimated gestational age 29-36 6/7 weeks or birth weight 1400-2500g
* Delivery in the hospital

Exclusion Criteria:

* Infant admitted to the NICU
* Birth weight less than 1400 gms
* Abdominal wall defect or myelomeningocele
* Major congenital anomalies
* Blistering skin disorder

Primary outcomes:
measure: Axillary temperature < 36.5 degrees Celsius
timeFrame: Discharge or 24 hours after birth
Secondary outcomes:
measure: Seizure
timeFrame: Up to 4 weeks
measure: Respiratory Distress Syndrome (RDS)
timeFrame: Up to 4 weeks
measure: Pneumothorax
timeFrame: Up to 4 weeks
measure: Sepsis
timeFrame: Up to 4 weeks
measure: Necrotizing enterocolitis or intestinal perforation
timeFrame: Up to 4 weeks
measure: Death
timeFrame: Up to 4 weeks
measure: Hyperthermia
timeFrame: Up to 4 weeks
measure: Temperature and humidity
timeFrame: 1-72 hours after birth
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: