Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects

Официальное название

CATAMARAN - Pediatrics : Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects

Обзор

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.

Вмешательства

• Другое Blood sampling
  An EDTA blood sample will be taken from the children and their two parents. Sample volume will be 2 x 3mL.
• Диагностический тест Assessment of neurodevelopment (CA)
  The children will be seen by a neuropsychologist, who will then determine whether or not they have neurodevelopmental disorders.
• Диагностический тест Assessment of neurodevelopment (Nantes)
  The children will be seen by a multidisciplinary team (including a neuropsychologist), who will then determine whether or not they have neurodevelopmental disorders.
• Другое Assessment of the parental stress
  Parents' parental stress will be assessed using the Parental Stress Index (PSI) questionnaire.

Первичные конечные точки

• Assessment of the prevalence of neurodevelopmental disorders in children aged 3-11 years with critical congenital heart defects. [Срок оценки: 14 days]

Вторичные конечные точки (7)

• Identify rare genetic variants associated with genome-wide neurodevelopmental disorders in patients with congenital heart defects. [Срок оценки: One day]
• Identify frequent genetic variants associated with genome-wide neurodevelopmental disorders in patients with congenital heart defects. [Срок оценки: 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). [Срок оценки: up to 14 days]
• Evaluate and describe the neurodevelopmental domains affected in the pediatric population of Nantes (Multidisciplinary assessment). [Срок оценки: up to 14 days]
• Assessment of the quality of life and psychopathological aspects of the child as well as parental stress. [Срок оценки: up to 14 days]
• Assessment of diagnostic accuracy (of NDD) provided by an innovative multidisciplinary approach. [Срок оценки: 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). [Срок оценки: up to 14 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Genetic anomaly or malformative syndrome associated with neurodevelopmental abnormalities, identified prior to inclusion
• Neurodevelopmental assessment not practicable

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Франция · 5 центров

• Chu Brest — Brest
• CHU Rennes — Rennes
• CHU Nantes — Nantes
• CHU Angers — Angers
• CHU Tours — Tours

Идентификаторы

NCT: NCT06442592 · RC23_0548 · 2024-A00428-39

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗