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

Study Overview
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Brief Summary
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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
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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%.

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

Conditions
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Hypothermia, Immature Newborn

Intervention / Treatment
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* Procedure: Resuscitation-torso plastic bag
* Procedure: Resuscitation-partial-head plastic bag


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 1 Hour

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Resuscitation-torso plastic bag<br>Resuscitation with plastic bag covering torso and lower extremities for first hour to assist with temperature regulation. | Procedure: Resuscitation-torso plastic bag<br>* Infant's extremities and torso will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth.<br>|
| Active Comparator: Resuscitation-partial-head plastic bag<br>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. | Procedure: Resuscitation-partial-head plastic bag<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axillary temperature < 36.5 degrees Celsius | 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 | 1-72 hours after birth | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypothermia, Low birth Weight, Newborn, Resuscitation, Plastic bag