CATAMARAN - Pediatrics : Characterization and Support for Neurodevelopmental Disorders Associated with Congenital Heart Defects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,206
- 试验地点
- 10
- 主要终点
- Assessment of the prevalence of neurodevelopmental disorders in children aged 3-11 years with critical congenital heart defects.
研究概览
简要总结
The leading cause of birth defects, Congenital Heart Defects (CHD) affect 12 million people worldwide and 41,000 newborns/year in Europe. It's a major cause of life-long morbidity and mortality, and a crucial public health issue. More than 50% of childs born with critical CHD will develop Neurodevelopmental Disorders (NDs), requiring specific care and impairing quality of life. NDs corresponds to early and lasting disturbances in cognitive, affective and behavioral development, linked to abnormalities in brain development. They are heterogeneous, affecting language, learning, motor skills, intellectual efficiency, social cognition, attention, memory and executive functions, and are associated with psychosocial difficulties (adaptive behavior, social interactions). This hidden handicap is the main long-term sequels of CHD, even before cardiovascular sequels, in individuals who often underwent multiple heart operations in early childhood. NDs concern not only complex CHD, but also simple CHD repaired in childhood and considered cured.
The origin of TND associated with CHD is largely unknown. To date, few genetic or environmental causes have been clearly identified, but recent work has suggested that a common origin may link cardiac malformation and neurodevelopmental abnormality.
The CATAMARAN - Pediatrics project is designed to detect potential neurodevelopmental delays associated with CHD as early as age 3, and to identify individual susceptibility factors involved in the occurrence of NDs in CHD children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child (aged 3 to 11) with critical MCC operated on for heart surgery during the first three months of life
- •Parents and child affiliated with or benefiting from a social security or similar scheme
- •Parents' and child's good understanding of the French language
- •Free, informed and written consent of both parents for themselves and for the child
- •Free, informed and written consent of the child aged 6 and over
- •Biological parents
排除标准
- •Genetic anomaly or malformative syndrome associated with neurodevelopmental abnormalities, identified prior to inclusion
- •Neurodevelopmental assessment not practicable
结局指标
主要结局
Assessment of the prevalence of neurodevelopmental disorders in children aged 3-11 years with critical congenital heart defects.
时间窗: 14 days
次要结局
- Identify rare genetic variants associated with genome-wide neurodevelopmental disorders in patients with congenital heart defects.(One day)
- Identify frequent genetic variants associated with genome-wide neurodevelopmental disorders in patients with congenital heart defects.(One day)
- Assessment of the prevalence of neurodevelopmental disorders in children with critical congenital heart defects in each age subgroup (3-5, 6-8, and 9-11 years).(up to 14 days)
- Evaluate and describe the neurodevelopmental domains affected in the pediatric population of Nantes.(up to 14 days)
- Assessment of the quality of life and psychopathological aspects of the child as well as parental stress.(up to 14 days)
- Assessment of diagnostic accuracy (of NDD) provided by an innovative multidisciplinary approach.(up to 14 days)
- Describe the different types of neurodevelopmental disorders (number and nature of neurodevelopmental domains affected) in each age subgroup (intelligence, oral language, motor skills, school learning, executive functions, social interactions).(up to 14 days)