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

Not Applicable

Active, not recruiting

Interventions: Procedure: Resuscitation-torso plastic bag
Procedure: Resuscitation-partial-head 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 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%.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Resuscitation-torso plastic bag	Resuscitation-torso plastic bag	Resuscitation with plastic bag covering torso and lower extremities for first hour to assist with temperature regulation.
Resuscitation-partial-head plastic bag	Resuscitation-partial-head plastic bag	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.

Primary Outcome Measures

Name	Time	Method
Axillary temperature < 36.5 degrees Celsius	1-72 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 will be classified as severe hypothermia

Secondary Outcome Measures

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