Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part II
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01604421|
Recruitment Status : Recruiting
First Posted : May 23, 2012
Last Update Posted : November 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hypothermia||Procedure: Thermoregulation-standard care Procedure: Thermoregulation with plastic bag||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||182 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 II|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2019|
Sham Comparator: Thermoregulation-standard care
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
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.
Active Comparator: Thermoregulation-with plastic bag
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
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.
- Axillary temperature < 36.5 degrees Celsius [ Time Frame: Discharge or 24 hours after birth ]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.
- Seizure [ Time Frame: Up to 4 weeks ]Seizure activity diagnosed by medical director or nurse. No electroencephalogram will be done.
- 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
- 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
- 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.
- 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 one minute
- Temperature and humidity [ Time Frame: 1-72 hours after birth ]A recording of the room temperature and humidity will be obtained with each axillary temperature measurement
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604421
|Contact: Waldemar A Carlo, MDfirstname.lastname@example.org|
|Contact: Theodore C Belsches, MS4email@example.com|
|University Teaching Hospital||Recruiting|
|Contact: Elwyn Chomba, MD firstname.lastname@example.org|
|Sub-Investigator: Theodore C Belsches, MS4|
|Sub-Investigator: Rohan Kambeyanda, MS4|
|Sub-Investigator: Tonya R Miller, MS4|
|Sub-Investigator: Alyssa E Tilly, MS4|
|Principal Investigator:||Waldemar A Carlo, MD||University of Alabama at Birmingham|