Screening for Neurodevelopmental Disorders in Children With Congenital Heart Disease Aged From 6 to 66 Months in Nord-Pas-de-Calais
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 233
- 试验地点
- 1
- 主要终点
- Percentage of children classified "at risk" for neuro-developmental disorders by the Age & Stage Questionnaire Third Edition in French (ASQ3) score
研究概览
简要总结
Children with congenital heart disease are at risk for neurodevelopmental disorders, these disorders impacting their quality of life and their integration into society.
The aim of this study is to detect neurodevelopmental disorders in children (aged from 6 to 66 months) with congenital heart disease in Nord-Pas-De-Calais (France) and to evaluate the frequency and risk factors of these neurodevelopmental disorders for a better follow-up.
This study will help implementing a specific program for the evaluation and management of neurodevelopmental disorders in children suffering from congenital heart disease in Nord-Pas-De-Calais and more globally, in the region Hauts-De-France.
详细描述
Are selected children with "significant" congenital heart disease (aged from 6 to 66 months) in "Nord-Pas-De-Calais" fulfilling inclusion criteria. A reliable and valid questionnaire used to screen developmental delays of children aged from one month to 66 months is completed by volunteer parents at the time of the study. Data of the questionnaire is collected and a scoring by professional is provided ; children at risk for neurodevelopmental delays are depicted.
In parallel, medical and surgical history is also collected to detect risk factors for neurodevelopmental disorders.
The frequency of neurodevelopmental disorders in this screened population according to risk factors (among neonatal data, severity of congenital heart disease, surgery, length of stay at hospital,... ) will be evaluated. The ratio children with neurodevelopmental disorders for whom specific care was implemented/ children with neurodevelopmental disorders who did not have specific care despite neurodevelopmental disorders will be established.
Follow-up action will be taken for children at risk for developping neurological disorders highlighted by the screening.
This study will help implementing a specific program for evaluation and management of neurodevelopmental disorders for children with congenital heart disease in our region.
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
- 6 Months 至 66 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6 to 66 months at the time of study
- •living in region "Nord-Pas-De-Calais"
- •with " significant" congenital heart disease (= complex congenital heart diseases operated or not, simple or moderate congenital heart disease who had cardiac surgery)
- •Followed by the Pediatric Cardiology Department of Lille University Hospital, or patients having a cardiopediatric follow-up outside Lille University Hospital but having been taken in charge at the University Hospital of Lille for any reason (cardiac or not)
排除标准
- •lost to sight
- •with congenital heart disease, living in Nord-Pas-de-Calais but never having been taken in charge at Lille University Hospital
- •with mild or moderate congenital heart disease not having undergone surgery or having only undergone cardiac catheterization
- •with cardiac surgery not performed in the Centers of Jacques CARTIER and Marie LANNNELONGUE
结局指标
主要结局
Percentage of children classified "at risk" for neuro-developmental disorders by the Age & Stage Questionnaire Third Edition in French (ASQ3) score
时间窗: Baseline: one session
The ASQ3 evaluates neurodevelopment in children by a parental questionnaire. ASQ-3 score screens 5 neurodevelopmental areas (communication, gross motor, fine motor, problem solving and personal-social); 30 items per questionnaire about the child's skills are evaluated. Each item could be range between Yes (The child do the action - 10 points), Sometimes (5 points) or Not yet (0 point). The scale for each areas could be from 0 (worse outcome) to 60 points (best outcome). The different areas scores are referred in a chart specific of each questionnaire. In each area the score indicates if the child's development appears to be on schedule (best outcome), need learning and attention or need to be evaluated by a professional (worse outcome, - 2 SD from the global population).
次要结局
- Frequency of neurodevelopmental disorders in children with congenital heart disease in this screened population(Baseline: one session)
- Number of Children With Documented Risk Factors for neurodevelopmental disorders(Baseline: one session)
- Frequency of neurodevelopmental disorders according to the severity of congenital heart disease(Baseline: one session)
- Ratio of children with neurodevelopmental disorders and for whom specific care was implemented(Baseline: one session)