NCT02814539已完成不适用
Brain Network Function in School-age Children With Congenital Heart Disease and Its Relation to Higher Order Cognitive Functions
Bea Latal0 个研究点目标入组 50 人开始时间: 2016年3月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Executive Functions, assessed with D-KEFS
研究概览
简要总结
The purpose of the study is to determine whether the neurodevelopmental outcome and in particular executive functions in 9 to 14 year old school children with congenital heart disease who underwent cardiopulmonary bypass surgery during their first three months of life is impaired in comparison to healthy children at same age. Executive functions are higher order cognitive functions and critical for school success.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 9 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Congenital heart disease,
- •Cardiopulmonary bypass surgery during first three months of life,
- •No genetic syndrome,
- •Gestational age > 37 weeks of gestation.
排除标准
- •Heart surgery without cardiopulmonary bypass,
- •Heart surgery not within first three months of life,
- •Born <37 weeks of gestation,
- •Any genetic syndrome detected.
结局指标
主要结局
Executive Functions, assessed with D-KEFS
时间窗: 2 years
次要结局
- slow wave activity on EEG(2 years)
- MRI volumetry(2 years)
研究者
Bea Latal
Prof Dr med Bea Latal
University Children's Hospital, Zurich
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