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

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 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
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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%.

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

Conditions
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Hypothermia

Intervention / Treatment
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* Procedure: Thermoregulation-standard care
* Procedure: Thermoregulation with plastic bag


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Estimated gestational age 29-36 6/7 weeks or birth weight 1400-2500g Delivery in the hospital Exclusion Criteria: Infant admitted to the NICU Birth weight less than 1400 gms Abdominal wall defect or myelomeningocele Major congenital anomalies Blistering skin disorder

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 120 Days

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 |
| --- | --- |
| Sham Comparator: Thermoregulation-standard care<br>Standard thermoregulation without a plastic bag from one hour after birth until discharge or 24 hours after birth, whichever comes first. | Procedure: Thermoregulation-standard care<br>* Standard care without plastic bag. One hour after birth, a blanket will be wrapped around the infant and he/she will receive a wool hat, according to standard practices. The infant's axillary temperature will be monitored for 24 hours or until discharge, whichever comes first.<br>|
| Active Comparator: Thermoregulation-with plastic bag<br>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. | Procedure: Thermoregulation with plastic bag<br>* One hour after birth, the infant will be placed into a plastic bag up to his/her axillae, and the bag will be folded and taped to itself to prevent it from covering the infant's nose or mouth. A blanket will be wrapped around the infant, and he/she will receive a wool hat. The infant will remain in the bag, which will be changed when soiled, for 24 hours or until discharge, whichever occurs first.<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 as severe hypothermia. | Discharge or 24 hours after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure | Seizure activity diagnosed by medical director 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 1. | 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, Plastic bag, Thermoregulation