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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01989026 |
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Date of registration:
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07/10/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Randomized Trial of Providing BCG Vaccination Immediately
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Scientific title:
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Reducing Mortality at the Neonatal Intensive Care Unit in Guinea-Bissau: A Randomized Trial of Providing BCG Vaccination Immediately |
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Date of first enrolment:
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October 2013 |
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Target sample size:
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3361 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01989026 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Care Provider).
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Phase:
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Phase 4
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Countries of recruitment
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Guinea-Bissau
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Contacts
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Name:
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Christine Stabell Benn, MD, PhD, DMSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Research Center for Vitamins and Vaccines |
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Name:
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Morten Bjerregaard-Andersen, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Research Center for Vitamins and Vaccines |
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Name:
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Peter Aaby, Prof, DMSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bandim Health Project |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children admitted to the neonatal intensive care unit
Exclusion Criteria:
- Birth weight<1250 g
- Apgar score<2
- Moribund children and children with gross malformations
Age minimum:
N/A
Age maximum:
30 Days
Gender:
All
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Health Condition(s) or Problem(s) studied
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Early Neonatal Mortality
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Intervention(s)
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Biological: BCG
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Primary Outcome(s)
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Mortality
[Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days.]
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Secondary Outcome(s)
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Cause of death
[Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days.]
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Duration of admission
[Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days]
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Growth
[Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 6 days.]
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Secondary ID(s)
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CVK-2013-1303771
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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