Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT02189759 |
Date of registration:
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11/07/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Kangaroo Mother Care to Prevent Hypothermia in Term Infants
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Scientific title:
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A Randomized Trial of Kangaroo Mother Care to Prent Neonatal Hypothermia - Trials 2A & 2 B |
Date of first enrolment:
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August 2014 |
Target sample size:
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375 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02189759 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Zambia
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Contacts
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Name:
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Manimaran Ramani, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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University of Alabama at Birmingham |
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Name:
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Waldemar A Carlo, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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University of Alabama at Birmingham |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Estimated gestational age greater than or equal to 37 weeks
- Delivery in the hospital
Exclusion Criteria:
- Abdominal wall defect or myelomeningocele
- Major congenital anomalies
- Blistering skin disorder
Age minimum:
N/A
Age maximum:
2 Weeks
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypothermia
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Newborn
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Intervention(s)
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Other: Continuous Kangaroo Mother Care to one hour after birth
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Other: Continuous Kangaroo Mother Care to discharge
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Other: Standard Kangaroo Mother Care to discharge
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Other: Standard Kangaroo Mother Care to one hour after birth
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Primary Outcome(s)
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Number of Infants With Axillary Temperature < 36.0 Degrees Celsius at Discharge
[Time Frame: At discharge or 24 hours after birth (whichever is first)]
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Number of Infants With Axillary Temperature <36.0 Degrees Celsius
[Time Frame: Time of birth to 1 hour]
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Secondary Outcome(s)
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Duration of Kangaroo Mother Care
[Time Frame: Duration of hospitalization-an average of 2 weeks]
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Number Infants Admitted to the Neonatal Intensive Care Unit
[Time Frame: Duration of hospitalization-an average of 2 weeks]
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Secondary ID(s)
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UAB Neo 012
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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