Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442592
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-29
Brief Title:
Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
CATAMARAN - Pediatrics Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CATAMARAN Ped
Brief Summary:
The leading cause of birth defects Congenital Heart Defects CHD affect 12 million people worldwide and 41000 newbornsyear in Europe Its 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-A00428-39 | OTHER | ANSM IDRCB | None |