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

Not Applicable

Withdrawn

Interventions: Procedure: Thermoregulation-standard care
Procedure: Thermoregulation with plastic bag

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%.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Thermoregulation-standard care	Thermoregulation-standard care	Standard thermoregulation without a plastic bag from one hour after birth until discharge or 24 hours after birth, whichever comes first.
Thermoregulation-with plastic bag	Thermoregulation with plastic bag	Thermoregulation with plastic bag covering torso and lower extremities from one hour after birth until discharge or 24 hours after birth to assist with thermoregulation. The infant's axillary temperature will be monitored for 24 hours or until discharge, whichever comes first.

Primary Outcome Measures

Name	Time	Method
Axillary temperature < 36.5 degrees Celsius	Discharge or 24 hours 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 as severe hypothermia.

Secondary Outcome Measures

Name	Time	Method
Seizure	Up to 4 weeks	Seizure activity diagnosed by medical director or nurse. No electroencephalogram will be done.
Sepsis	Up to 4 weeks	Culture proven or culture negative clinically treated course consistent with sepsis
Necrotizing enterocolitis or intestinal perforation	Up to 4 weeks	Documentation of pneumatosis or intestinal perforation on x-ray or treatment course for clinical necrotizing enterocolitis per Bell's Classification stage greater than 1.
Hyperthermia	Up to 4 weeks	Axillary temperature \> 38 degrees Celsius per temperature taken per axilla for one minute
Pneumothorax	Up to 4 weeks	Either chest radiograph documentation or clinical deterioration consistent with air leak
Death	Up to 4 weeks	Cardiorespiratory failure
Respiratory Distress Syndrome (RDS)	Up to 4 weeks	Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant
Temperature and humidity	1-72 hours after birth	A recording of the room temperature and humidity will be obtained with each axillary temperature measurement