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
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): NCT01604317
|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|