Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part V
Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part V
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.
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%.
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