Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part I

Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part I

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.

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%.

Resuscitation with plastic bag covering torso and lower extremities for first hour to assist with temperature regulation.

Resuscitation with plastic bag covering torso, upper and lower extremities, and a portion of the head for first hour after birth to assist with temperature regulation.

Infant's extremities and torso will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth.

Infant's torso, extremities, and portion of the head (face will be exposed) will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth.

Temperature taken per axilla at one hour after birth. Temperatures 36.0-36.4 will be classified as mild hypothermia, 32.0-35.9 will be classified as moderate hypothermia, and < 32.0 will be classified as severe hypothermia

Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant

Documentation of pneumatosis or intestinal perforation on x-ray or treatment course for clinical necrotizing enterocolitis per Bell's classification stage greater than one.

A recording of the room temperature and humidity will be obtained with each axillary temperature measurement

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