Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04697147
Status:
COMPLETED
Last Update Posted:
2021-01-07
First Post:
2021-01-04
Brief Title:
Zika and Neurodevelopment Among Infants in Grenada
Sponsor:
Windward Islands Research and Education Foundation
Organization:
Windward Islands Research and Education Foundation
Study Overview
Official Title:
Rescuing Neurodevelopment in Zika-Exposed Infants in Grenada
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Implement a randomized controlled trial evidence-based culturally adapted environmental enrichment intervention for the purpose of enhancing neurocognitive outcomes among Zika Exposed Children
Detailed Description:
The intervention group received up to twelve 1-hour weekly visits by trained and experienced Grenadian parent and infant relationship specialists who provided home-based interventions as part of the Saving Brains Grenada project
The environmental enrichment intervention is a brain-based program that teaches parents about brain development in young infants and skills for building a strong social-emotional connection that stimulates brain development and maximizes neurocognitive function A detailed intervention manual was developed and used as a guide for the intervention specialists Neurocognitive outcomes in the intervention and control group were assessed pre and post intervention by a separate and blinded assessment team
The environmental enrichment intervention is a brain-based program that teaches parents about brain development in young infants and skills for building a strong social-emotional connection that stimulates brain development and maximizes neurocognitive function A detailed intervention manual was developed and used as a guide for the intervention specialists Neurocognitive outcomes in the intervention and control group were assessed pre and post intervention by a separate and blinded assessment team
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None