Zika and Neurodevelopment Among Infants in Grenada

Development, Child Clinical Trial

Official title:

Rescuing Neurodevelopment in Zika-Exposed Infants in Grenada

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04697147
• Other study ID #: SGUZIKV
• Status: Completed
• Phase: N/A
• Start date: September 3, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: January 2021
• Source: Windward Islands Research and Education Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Implement a randomized controlled trial, evidence-based, culturally adapted, environmental enrichment intervention for the purpose of enhancing neurocognitive outcomes among Zika Exposed Children.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Development, Child
• Neurocognitive Deficit
• Neurodevelopmental Abnormality
• Zika Virus Infection

Intervention

Behavioral:
• Conscious Discipline-Based Environmental Enrichment Intervention
Conscious Discipline, a social-emotional skills-based learning program that draws on current brain research and fosters enhanced connections between parents and their children.

Locations

Country	Name	City	State
Grenada	Windward Islands Research and Education Foundation (WINDREF)	Saint George's

Sponsors (4)

Lead Sponsor	Collaborator
Windward Islands Research and Education Foundation	National Institutes of Health (NIH), St. George's University, Stanford University

Country where clinical trial is conducted

Grenada, 

Outcome

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