Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates

Study Overview
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Brief Summary
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The overall hypothesis is that placing infants 1000-2500 grams in plastic bags when compared to routine care will reduce the risk of hypothermia (< 36.5 degrees C) without increasing hyperthermia (> 37.5 degrees C).

Detailed Description
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Prevention After consent, infants with estimated gestational age between 26-36.6 weeks or with expected birth weight 1000-2500 grams will be randomized to resuscitation per standard protocol or to resuscitation per standard protocol and plastic bag. The intervention group will be placed into a plastic bag covering the body and back and top of head (excluding face) prior to drying the body's surface. Resuscitation efforts continue per standard of care. The infant will remain in the bag through the admission process until his/her axillary temp is in the range of 36.5- 37.5 degrees Celsius. At this time, the bag will be discontinued and discarded. Standard temperature control will be continued per nursery standard. Skin-to-skin contact between mother and baby is not excluded; however, the infant will remain in the plastic bag. Infant's axillary temperature will be measured per nursery standard after discontinuation of plastic bag. The control group will receive standard of care thermoregulation. Secondary measures (i.e. blood pressures, glucose levels, weight gain, observation for respiratory distress syndrome, bronchopulmonary dysplasia, pneumothorax, sepsis, seizures, intraventricular hemorrhage, necrotizing enterocolitis, pulmonary hemorrhage, and death) will be recorded in both groups.

Official Title
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A Randomized Trial to Evaluate the Use of Plastic Bags in Preventing and Treating Hypothermia in Neonates in Developing Countries

Conditions
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Hypothermia, Newborn

Intervention / Treatment
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* Procedure: Resuscitation and post resuscitation care with plastic bag
* Procedure: Resuscitation- no plastic bag for temperature regulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Estimated gestational age 26-36.6 weeks or expected birth weight 1000-2500 grams. Delivery in the hospital. Exclusion Criteria: Abdominal wall defect or myelomeningocele. Major congenital anomaly. Blistering skin disorder.
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 with plastic bag<br>Plastic bag will be used during and after resuscitation to assist with temperature regulation. | Procedure: Resuscitation and post resuscitation care with plastic bag<br>* Infant will be resuscitated and placed in a plastic bag up to his/her neck and around the back of his head (not covering the face) in the delivery room and taken to the nursery. The infant will remain in the plastic bag until first axillary temperature remains stable at 36.5-37.5 degrees Celsius. Expected length of time approximately one hour.<br>|
| Sham Comparator: Standard resuscitation- no plastic bag<br>Infant will be resuscitated per standard of care without being placed in a plastic bag for temperature regulation. | Procedure: Resuscitation- no plastic bag for temperature regulation<br>* Infant will be resuscitated in the delivery room and taken to the nursery. The infant will be observed per unit standard until first axillary temperature remains stable at 36.5-37.5 degrees Celsius. Expected length of time approximately one hour.<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 1 minute | 1-4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Measure of extremity blood pressure per cuff taken during nursery stay. | Duration of hospitalization-expected average of 4 weeks | 
| Blood glucose | Measure of blood glucose per laboratory value taken per heelstick | Duration of hospitalization-expected average of 4 weeks | 
| Seizure | Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done. | Duration of hospitalization-expected average of 4 weeks | 
| Weight gain | Infant will be weighed daily and rates of weight gain will be measured. | Duration of hospitalization-expected average of 4 weeks | 
| Respiratory Distress Syndrome (RDS) | Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant. | Duration of hospitalization-expected average of 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 | Duration of hospitalization-expected average of 4 weeks | 
| Sepsis | Culture proven or culture negative clinically treated course consistent with sepsis. | Duration of hospitalization-expected average of 4 weeks | 
| Major brain injury | Intracranial hemorrhage Grade 3-4 or periventricular leukomalacia documented on cranial ultrasound | Duration of hospitalization-expected average of 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 stage greater than one. | Duration of hospitalization-expected average of 4 weeks | 
| Pulmonary hemorrhage | Blood seen in the endotracheal tube and treated by physician. | Duration of hospitalization-expected average of 4 weeks | 
| Death | Cardiorespiratory failure | Duration of hospitalization-expected average of 4 weeks | 

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