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

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 V is comparing use of a plastic torso wrap to no plastic torso wrap in preterm/low birth weight infants following removal from their incubator to assist with temperature regulation.

Detailed Description
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Due to limited resources and numbers of incubators, hospitals in developing countries remove infants from incubators at lower weights than in developed countries, putting infants at increased risk for hypothermia. This study will compare the incidence of hypothermia during the 72 hours after incubator removal of infants randomized to receive standard incubator removal (control group) or standard incubator removal with a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken upon removal from the incubator, every subsequent 6-8 hours, and finally, at 72 hours as the bags are removed. Blood pressure, blood sugar, seizures, weight gain, hyperthermia, death, observation for respiratory distress, bronchopulmonary dysplasia, sepsis, intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, intestinal perforation, pulmonary hemorrhage room temperature and humidity, and length of time in an incubator will be recorded throughout their hospitalization for all infants. With an estimated hypothermia incidence of 30% and a hypothesized 20% absolute risk reduction (66% relative risk reduction), a sample size of 118 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 IV

Conditions
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Hypothermia

Intervention / Treatment
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* Procedure: Hypothermia prevention with plastic bag
* Procedure: Hypothermia prevention without plastic bag


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infant admitted to the NICU Current weight less than 2,000g Being removed from incubator Exclusion Criteria: 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: 72 Hours

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: Incubator removal-torso bag<br>Use plastic bag covering the torso and lower extremities for temperature regulation with standard bundling practices when removing infant from incubator | Procedure: Hypothermia prevention with plastic bag<br>* Upon removal from the incubator, infant will be placed into a plastic bag 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. The infant will be wrapped in a blanket and receive a cloth hat. The bag will be changed when soiled and the infant will remain in the bag for 72 hours or until discharge, whichever comes first. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.<br>|
| Placebo Comparator: Incubator removal-no plastic bag<br>Standard bundling practices when removing the infant from the incubator. No plastic bag used. | Procedure: Hypothermia prevention without plastic bag<br>* Upon removal from incubator, the infant will be wrapped in a blanket and receive a cloth hat, according to standard bundling practices. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axillary temperature 36.5-37.5 degrees Celsius | Temperature taken per axilla for one minute | 1-72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Measure of extremity blood pressure per cuff taken during nursery stay | Up to 4 weeks | 
| Blood glucose | Measure of blood glucose per laboratory value taken per heel stick | Up to 4 weeks | 
| Seizure | Seizure activity diagnosed by medical doctor or nurse. No electoencephalogram will be done. | Up to 4 weeks | 
| Weight gain | Infant will be weighed daily and rates of weight gain will be calculated | 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 | 
| Bronchopulmonary Dysplasia (BPD) | Oxygen requirement at 28 days of life | 28 days after birth | 
| 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 | 
| Major brain injury | Intracranial hemorrhage grade 3-4 or periventricular leukomalacia documented on cranial ultrasound | 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 | 
| Pulmonary hemorrhage | Blood seen in the endotracheal tube and treated by physician | Up to 4 weeks | 
| Death | Cardiorespiratory failure | Up to 4 weeks | 
| Hyperthermia | Axillary temperature > 38 degrees Celsius per temperature taken per axilla for 1 minute | Up to 4 weeks | 
| Length of time in incubator | Documentation of length of time spent in incubator and number of times placed in incubator | Up to 4 weeks | 
| Room temperature and humidity | A recording of the room temperature and humidity will be obtained with each axillary temperature measurement | 1-72 hours | 
| Incubator temperature and humidity | A recording of the air temperature and humidity with the incubator will be obtained with each axillary temperature measurement | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypothermia, Newborn, Incubator, Plastic bag, Normothermia