Development, Child Clinical Trial
Official title:
Rescuing Neurodevelopment in Zika-Exposed Infants in Grenada
Verified date | January 2021 |
Source | Windward Islands Research and Education Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Implement a randomized controlled trial, evidence-based, culturally adapted, environmental enrichment intervention for the purpose of enhancing neurocognitive outcomes among Zika Exposed Children.
Status | Completed |
Enrollment | 148 |
Est. completion date | February 28, 2020 |
Est. primary completion date | February 22, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 24 Months to 30 Months |
Eligibility | Inclusion Criteria: - Must be actively enrolled in the pre-existing Zika Cohort Study - Infant must be alive and living with a parent/guardian at the time of recruitment - Infant must be between 24-27 months at the time of recruitment Exclusion Criteria: - Any infants older than 27 months - Persons not enrolled in the pre-existing Zika Cohort Study |
Country | Name | City | State |
---|---|---|---|
Grenada | Windward Islands Research and Education Foundation (WINDREF) | Saint George's |
Lead Sponsor | Collaborator |
---|---|
Windward Islands Research and Education Foundation | National Institutes of Health (NIH), St. George's University, Stanford University |
Grenada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The INTERGROWTH 21st Neurodevelopmental Assessment (INTER-NDA) | The INTER-NDA is a measure of cognition, motor skills (fine and gross motor), language (expressive and receptive), behavior, executive function, attention and social-emotional reactivity for 2-year-olds. The measure is comprised of 30 items scored across a spectrum, with higher scores indicating better outcomes. | 22-30 months |
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