Clinical trial NCT01604460: Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part V
Official title: Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part V
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypothermia
Newborn
Keywords: Hypothermia
Newborn
Plastic bag
Resuscitation
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Children's Health System, Alabama
First posted: 2012-05-23
Enrollment: 275
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 standard WHO thermoregulation practices plus use of a plastic torso wrap to no plastic torso wrap in full term infants from resuscitation to one hour after birth.

Detailed description: Due to delivery rooms without adequate climate controls, even full term infants have high rates of hypothermia in the developing world. This study will compare the rates of hypothermia one hour after birth in full term infants randomized to receive standard WHO thermoregulation care (control group) or standard WHO thermoregulation care without immediate drying plus a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken within 15 minutes of birth at at one hour after birth with removal of the plastic bag. Hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 15% and a hypothesized 10% absolute risk reduction (66% relative risk reduction), a sample size of 276 will be used to have a power of 80% and a confidence interval of 95%.

Eligibility criteria: Inclusion Criteria:

* Estimated gestational age 37 weeks and greater
* Birth weight greater than 2,500gms
* Delivery in the hospital

Exclusion Criteria:

* Infant admitted to the NICU
* Birth weight less than 2,500gms
* Abdominal wall defect or myelomeningocele
* Major congenital anomalies
* Blistering skin disorder

Primary outcomes:
measure: Axillary temperature < 36.5 degrees Celsius
timeFrame: 1-72 hours
Secondary outcomes:
measure: Sepsis
timeFrame: Up to 72 hours
measure: Death
timeFrame: Up to 72 hours
measure: Hyperthermia
timeFrame: Up to 72 hours
measure: Room Temperature
timeFrame: 1-72 hours
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:
citation: Belsches TC, Tilly AE, Miller TR, Kambeyanda RH, Leadford A, Manasyan A, Chomba E, Ramani M, Ambalavanan N, Carlo WA. Randomized trial of plastic bags to prevent term neonatal hypothermia in a resource-poor setting. Pediatrics. 2013 Sep;132(3):e656-61. doi: 10.1542/peds.2013-0172. Epub 2013 Aug 26.