NCT01632813已完成不适用
Neurocognitive Development in Children With Congenital Heart Disease: Growing Into Deficit
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- reaction time (RT) and error rates of inhibitory control (Response Organization Objects, ROO) (Amsterdam Neuropsychological Tasks, ANT)
研究概览
简要总结
The key objective of the Leuven growing-into-deficit (GID) follow-up-study is to test the hypothesis that children with a congenital heart disease (CHD) show more neurocognitive impairment at the second follow-up at 7 years old than at the first follow-up at the age of 4, compared to healthy controls.
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
- 84 Months 至 89 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Seven-year-old children with CHD and healthy control children who were four years old when they participated in Paediatric ICU follow-up study (i.e. first follow-up time point) (Neurocognitive development of children four years after critical illness and treatment with tight glucose control, Clinical Trials # NCT00214916). The children of the CHD-group underwent cardiac surgery as infants (=<1year).
排除标准
- •Genetic syndromes (Down, 22q11del), known to result in neurocognitive impairment
- •Lack of baseline neurocognitive measurements during first follow-up
- •Date of birth before February 2005
结局指标
主要结局
reaction time (RT) and error rates of inhibitory control (Response Organization Objects, ROO) (Amsterdam Neuropsychological Tasks, ANT)
时间窗: one testpoint at age of 7 years
次要结局
- Number of taps on computerized tapping tasks (ANT)(one testpoint at age of 7 years)
- IQ measures (Revised Wechsler Preschool and Primary Scale of Intelligence, WPPSI-R)(one testpoint at age of 7 years)
- Visual-Motor Integration total standard score (VMI)(one testpoint at age of 7 years)
- Child Behavior CheckList T-scores for internalizing and externalizing problems(one testpoint at age of 7 years)
- Pediatric Quality of Life Inventory - Generic Score Scales (PedsQL) to quantify quality of life(one testpoint at age of 7 years)
- reaction time (RT) and error rates of cognitive flexibility (ROO, ANT) and working memory (Memory Search - Objects 2 Keys, ANT)(one testpoint at age of 7 years)
- Mean RT + standard deviation (SD) of RT on computerized alertness task (Baseline Speed, ANT)(one testpoint at age of 7 years)
- Behavior Rating Inventory of Executive Function (BRIEF) to measure executive functions (parent and teacher version)(one testpoint at age of 7 years)
- Teacher Report Form (TRF) T-scores for internalizing and externalizing problems at school(one testpoint at age of 7 years)
- Incidence of medical problems (e.g. head trauma), interventions and operations since first follow-up(one testpoint at age of 7 years)
研究者
Greet Van den Berghe
Head of Dept Intensive Care Medicine
KU Leuven
研究点 (1)
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