Rescuing Neurodevelopment in Zika-Exposed Infants in Grenada
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- The INTERGROWTH 21st Neurodevelopmental Assessment (INTER-NDA)
研究概览
简要总结
Implement a randomized controlled trial, evidence-based, culturally adapted, environmental enrichment intervention for the purpose of enhancing neurocognitive outcomes among Zika Exposed Children.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Neurocognitive assessors are blinded to which participants have received the intervention during their longitudinal visits.
入排标准
- 年龄范围
- 24 Months 至 30 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Any infants older than 27 months
- •Persons not enrolled in the pre-existing Zika Cohort Study
结局指标
主要结局
The INTERGROWTH 21st Neurodevelopmental Assessment (INTER-NDA)
时间窗: 22-30 months
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.
次要结局
未报告次要终点
研究者
Dr. Randall Waechter
Associate Director of Research
Windward Islands Research and Education Foundation