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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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8 August 2016 |
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Main ID: |
NCT02448615 |
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Date of registration:
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15/05/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Birth Cohort in Coast Province, Kenya
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Scientific title:
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A Longitudinal Birth Cohort Study in Coast Province, Kenya |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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283 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02448615 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Kenya
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Contacts
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Name:
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Shaun K Morris, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Hospital for Sick Children |
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Name:
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Robert Armstrong, 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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Aga Khan University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
i. All pregnant women and their home- or facility-born live newborns that consent to
participate in the control arm of the study "An integrated toolkit to save newborn lives
and brains in Kenya" (NCT02208960) will be eligible for this study. The maternal inclusion
criteria will be:
1. All pregnant women in parts of study clusters covered by CHW program and their home-
or facility-born live newborns.
2. Mothers intending to maintain residence in study area for first 12 months of
newborn's life.
Exclusion Criteria:
i. Did not consent to participate in the control arm of "An integrated toolkit to save
newborn lives and brains in Kenya" (NCT02208960).
ii. Failure to provide consent to enroll in this study.
Age minimum:
N/A
Age maximum:
1 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Child Development
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Mortality
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Morbidity
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Child Behaviour
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Primary Outcome(s)
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Child mortality within the first year of life
[Time Frame: 12 months (Day 3 of life, Month 6 of life, Month 12 of life)]
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Secondary Outcome(s)
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Development/behaviour of children aged 6 and 12 months in the Coast Province, Kenya
[Time Frame: Month 6 of life, Month 12 of life]
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Morbidity within the first year of a child's life
[Time Frame: 12 months (Day 3 of life, Month 6 of life, Month 12 of life)]
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Secondary ID(s)
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1000047574
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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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