Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part IV
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|ClinicalTrials.gov Identifier: NCT01604447|
Recruitment Status : Completed
First Posted : May 23, 2012
Last Update Posted : February 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hypothermia||Procedure: Hypothermia prevention with plastic bag Procedure: Hypothermia prevention without plastic bag||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part IV|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||February 2015|
Active Comparator: Incubator removal-torso bag
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
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.
Placebo Comparator: Incubator removal-no plastic bag
Standard bundling practices when removing the infant from the incubator. No plastic bag used.
Procedure: Hypothermia prevention without plastic bag
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.
- Axillary temperature 36.5-37.5 degrees Celsius [ Time Frame: 1-72 hours ]Temperature taken per axilla for one minute
- Blood pressure [ Time Frame: Up to 4 weeks ]Measure of extremity blood pressure per cuff taken during nursery stay
- Blood glucose [ Time Frame: Up to 4 weeks ]Measure of blood glucose per laboratory value taken per heel stick
- Seizure [ Time Frame: Up to 4 weeks ]Seizure activity diagnosed by medical doctor or nurse. No electoencephalogram will be done.
- Weight gain [ Time Frame: Up to 4 weeks ]Infant will be weighed daily and rates of weight gain will be calculated
- Respiratory Distress Syndrome (RDS) [ Time Frame: Up to 4 weeks ]Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant
- Bronchopulmonary Dysplasia (BPD) [ Time Frame: 28 days after birth ]Oxygen requirement at 28 days of life
- Pneumothorax [ Time Frame: Up to 4 weeks ]Either chest radiograph documentation or clinical deterioration consistent with air leak
- Sepsis [ Time Frame: Up to 4 weeks ]Culture proven or culture negative clinically treated course consistent with sepsis
- Major brain injury [ Time Frame: Up to 4 weeks ]Intracranial hemorrhage grade 3-4 or periventricular leukomalacia documented on cranial ultrasound
- Necrotizing enterocolitis or intestinal perforation [ Time Frame: 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 1.
- Pulmonary hemorrhage [ Time Frame: Up to 4 weeks ]Blood seen in the endotracheal tube and treated by physician
- Death [ Time Frame: Up to 4 weeks ]Cardiorespiratory failure
- Hyperthermia [ Time Frame: Up to 4 weeks ]Axillary temperature > 38 degrees Celsius per temperature taken per axilla for 1 minute
- Length of time in incubator [ Time Frame: Up to 4 weeks ]Documentation of length of time spent in incubator and number of times placed in incubator
- Room temperature and humidity [ Time Frame: 1-72 hours ]A recording of the room temperature and humidity will be obtained with each axillary temperature measurement
- Incubator temperature and humidity [ Time Frame: 1 hour ]A recording of the air temperature and humidity with the incubator will be obtained with each axillary temperature measurement
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604447
|University Teaching Hospital|
|Principal Investigator:||Waldemar A Carlo, MD||University of Alabama at Birmingham|