- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01604460
Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part V
February 8, 2013 updated by: Waldemar A. Carlo, MD, University of Alabama at Birmingham
Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part V
The overall hypothesis is that plastic bags used in combination with WHO thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine WHO thermoregulation care alone.
Part V is comparing standard WHO thermoregulation practices plus use of a plastic torso wrap to no plastic torso wrap in full term infants from resuscitation to one hour after birth.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Due to delivery rooms without adequate climate controls, even full term infants have high rates of hypothermia in the developing world.
This study will compare the rates of hypothermia one hour after birth in full term infants randomized to receive standard WHO thermoregulation care (control group) or standard WHO thermoregulation care without immediate drying plus a plastic bag covering their torsos and lower extremities (intervention group).
The axillary temperature of each infant will be taken within 15 minutes of birth at at one hour after birth with removal of the plastic bag.
Hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants.
With an estimated baseline hypothermia rate of 15% and a hypothesized 10% absolute risk reduction (66% relative risk reduction), a sample size of 276 will be used to have a power of 80% and a confidence interval of 95%.
Study Type
Interventional
Enrollment (Actual)
275
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lusaka, Zambia
- University Teaching Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 minute to 3 days (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Estimated gestational age 37 weeks and greater
- Birth weight greater than 2,500gms
- Delivery in the hospital
Exclusion Criteria:
- Infant admitted to the NICU
- Birth weight less than 2,500gms
- Abdominal wall defect or myelomeningocele
- Major congenital anomalies
- Blistering skin disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Resuscitation-no plastic bag
Resuscitation per standard of care without a plastic bag
|
Infant will be immediately dried and resuscitated in the delivery room per standard of care.
The infant will be wrapped in a blanket and will receive a cloth hat before being taken to the nursery.
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Active Comparator: Resuscitation-torso bag
Use of plastic bag covering the torso and lower extremities for temperature regulation during and after resuscitation for the first hour after birth
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Infant will be placed within 10 minutes of his birth 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.
After his/her head is dried, the infant will receive a cloth cap.
Resuscitation will occur in the delivery room and the infant will be wrapped in a blanket and taken to the nursery where he/she will remain in the plastic bag until 1 hour after birth.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Axillary temperature < 36.5 degrees Celsius
Time Frame: 1-72 hours
|
Temperature taken per axilla at one hour after birth.
Temperatures 36.0-16.4 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.
|
1-72 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sepsis
Time Frame: Up to 72 hours
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Culture proven or culture negative clinically treated course consistent with sepsis
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Up to 72 hours
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Death
Time Frame: Up to 72 hours
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Cardiorespiratory failure
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Up to 72 hours
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Hyperthermia
Time Frame: Up to 72 hours
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Axillary temperature > 38 degrees Celsius per axilla for one minute
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Up to 72 hours
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Room Temperature
Time Frame: 1-72 hours
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A recording of the room temperature will be obtained with each axillary temperature measurement
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1-72 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
May 21, 2012
First Submitted That Met QC Criteria
May 21, 2012
First Posted (Estimate)
May 23, 2012
Study Record Updates
Last Update Posted (Estimate)
February 11, 2013
Last Update Submitted That Met QC Criteria
February 8, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UAB Neo 010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Ain Shams UniversityCompletedRespiratory Distress Syndrome, NewbornEgypt
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Vanderbilt University Medical CenterCompletedEndotracheal Intubation | Respiratory Failure | Respiratory Failure With HypoxiaUnited States
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