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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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30 May 2022 |
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Main ID: |
NCT03393286 |
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Date of registration:
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22/12/2017 |
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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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ZIKAlliance Children Cohort (ZIKAllianceCH)
ZIKAllianceCH |
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Scientific title:
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Children (CH) Cohort for the Evaluation of Developmental and Neurological Abnormalities in Infants Born to Mothers Residing in Areas With Zika Virus Transmission During Pregnancy |
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Date of first enrolment:
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January 15, 2018 |
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Target sample size:
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1554 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03393286 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Bolivia
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Brazil
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Colombia
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Cuba
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Guadeloupe
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Mexico
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Venezuela
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Born within the Pregnant Woman cohort
- Born to mothers with confirmed ZIKA
Exclusion Criteria:
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Age minimum:
N/A
Age maximum:
6 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Zika Virus
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Primary Outcome(s)
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Congenital Abnormalities detected after birth as defined by the evolving definition of the congenital zika syndrome
[Time Frame: Birth]
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Developmental / cognitive abnormalities measured by the Ages and Stages 3rd Edition (ASQ3)
[Time Frame: Between birth and 2 years]
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Visual abnormalities measured after birth
[Time Frame: Between birth and 2 years]
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Developmental / cognitive abnormalities measured by the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III)
[Time Frame: 2 years]
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Hearing abnormalities measured after birth
[Time Frame: Between birth and 2 years]
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Secondary ID(s)
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734548CH (EC | H2020 | RIA)
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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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