Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part I
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|ClinicalTrials.gov Identifier: NCT01604317|
Recruitment Status : Recruiting
First Posted : May 23, 2012
Last Update Posted : November 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hypothermia Immature Newborn||Procedure: Resuscitation-torso plastic bag Procedure: Resuscitation-partial-head 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 I|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2019|
Active Comparator: Resuscitation-torso plastic bag
Resuscitation with plastic bag covering torso and lower extremities for first hour to assist with temperature regulation.
Procedure: Resuscitation-torso plastic bag
Infant's extremities and torso will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth.
Active Comparator: Resuscitation-partial-head plastic bag
Resuscitation with plastic bag covering torso, upper and lower extremities, and a portion of the head for first hour after birth to assist with temperature regulation.
Procedure: Resuscitation-partial-head plastic bag
Infant's torso, extremities, and portion of the head (face will be exposed) will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth.
- Axillary temperature < 36.5 degrees Celsius [ Time Frame: 1-72 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 will be classified as severe hypothermia
- Seizure [ Time Frame: Up to 4 weeks ]Seizure activity diagnosed by medical doctor 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 one.
- 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): NCT01604317
|Contact: Waldemar A Carlo, MDemail@example.com|
|Contact: Theodore C Belsches, MS4firstname.lastname@example.org|
|University Teaching Hospital||Recruiting|
|Contact: Elwyn Chomba, MD email@example.com|
|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|