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Zika and Neurodevelopment Among Infants in Grenada

Primary Purpose

Zika Virus Infection, Neurocognitive Deficit, Development, Child

Status
Completed
Phase
Not Applicable
Locations
Grenada
Study Type
Interventional
Intervention
Conscious Discipline-Based Environmental Enrichment Intervention
Sponsored by
Windward Islands Research and Education Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Zika Virus Infection

Eligibility Criteria

24 Months - 30 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Windward Islands Research and Education Foundation (WINDREF)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Waitlist Control

Arm Description

Immediately randomized to receive the intervention for 12 weeks.

Randomized to receive the intervention post-study.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 4, 2021
Last Updated
January 5, 2021
Sponsor
Windward Islands Research and Education Foundation
Collaborators
St. George's University, Stanford University, National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04697147
Brief Title
Zika and Neurodevelopment Among Infants in Grenada
Official Title
Rescuing Neurodevelopment in Zika-Exposed Infants in Grenada
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
February 22, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Windward Islands Research and Education Foundation
Collaborators
St. George's University, Stanford University, National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Zika Virus Infection, Neurocognitive Deficit, Development, Child, Neurodevelopmental Abnormality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Neurocognitive assessors are blinded to which participants have received the intervention during their longitudinal visits.
Allocation
Randomized
Enrollment
148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Immediately randomized to receive the intervention for 12 weeks.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
Randomized to receive the intervention post-study.
Intervention Type
Behavioral
Intervention Name(s)
Conscious Discipline-Based Environmental Enrichment Intervention
Intervention Description
Conscious Discipline, a social-emotional skills-based learning program that draws on current brain research and fosters enhanced connections between parents and their children.
Primary Outcome Measure Information:
Title
The INTERGROWTH 21st Neurodevelopmental Assessment (INTER-NDA)
Description
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.
Time Frame
22-30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
30 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randall Waechter, PhD
Organizational Affiliation
Windward Islands Research and Education Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Windward Islands Research and Education Foundation (WINDREF)
City
Saint George's
Country
Grenada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35259172
Citation
Waechter R, Burgen KS, Punch B, Evans R, Blackmon K, Noel T, Fernandes M, Landon B. Improving neurodevelopment in Zika-exposed children: A randomized controlled trial. PLoS Negl Trop Dis. 2022 Mar 8;16(3):e0010263. doi: 10.1371/journal.pntd.0010263. eCollection 2022 Mar.
Results Reference
derived

Learn more about this trial

Zika and Neurodevelopment Among Infants in Grenada

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