Clinical trial NCT01604317: Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part I
Official title: Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part I
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypothermia
Immature Newborn
Keywords: Hypothermia
Low birth Weight
Newborn
Resuscitation
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: 182
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
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 I is for preterm/low birth weight infant with or without plastic head cover used during resuscitation.

Detailed description: This study will compare the incidence of hypothermia during the first hour after birth in preterm/low birth weight infants randomized to receive WHO thermoregulation care and a plastic bag (without drying) covering the torso and lower extremities (control group) or WHO thermoregulation care and a plastic bag (without drying) covering the torso, upper and lower extremities, and a portion of their head (intervention group). The axillary temperature of each infant will be taken initially within 15 minutes of birth and later at 1 hour after birth as the infant is removed from the plastic bag. Seizures, hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 41% and a 21% absolute risk reduction (51% 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 6/7weeks or birth weight 1,400-2500g
* Delivery in the hospital

Exclusion Criteria:

* Infant admitted to the NICU
* Birth weight less than 1,400g
* Abdominal wall defect or myelomeningocele
* Major congenital anomalies
* Blistering skin disorder

Primary outcomes:
measure: Axillary temperature < 36.5 degrees Celsius
timeFrame: 1-72 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: