Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431269
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-17
Brief Title:
Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease
Sponsor:
University Hospital Montpellier
Organization:
University Hospital Montpellier
Study Overview
Official Title:
Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease
Status:
RECRUITING
Status Verified Date:
2024-08
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:
NEURODEV-IPA
Brief Summary:
Feasibility and efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children aged 1 to 5 with Congenital Heart Disease
Detailed Description:
Congenital heart disease CHD is the leading cause of birth defects Over 90 of children born with CHD reach adulthood 50 of them will develop a neurodevelopmental disorder NDD that could affect life and long-term prognosis including scholar and social integration and health related quality of life
In France there is a lack of medical resources to screen NDD in this population and to refer patients for appropriate and early treatment
Investigators plan to propose a systematic early screening of NDD by an Advanced Practice Nurse APN during the usual cardiac follow-up Children with CHD aged 1 to 5 will be included If NDD is suspected the patient will be referred to a neuropsychologist for NDD diagnosis confirmation and management planning Patients with higher NDD risks neonatal cardiac surgery will benefit from a systematic neuropsychologist evaluation
This study will investigate the feasibility and performance of an APN screening in this NDD-high risk population
In France there is a lack of medical resources to screen NDD in this population and to refer patients for appropriate and early treatment
Investigators plan to propose a systematic early screening of NDD by an Advanced Practice Nurse APN during the usual cardiac follow-up Children with CHD aged 1 to 5 will be included If NDD is suspected the patient will be referred to a neuropsychologist for NDD diagnosis confirmation and management planning Patients with higher NDD risks neonatal cardiac surgery will benefit from a systematic neuropsychologist evaluation
This study will investigate the feasibility and performance of an APN screening in this NDD-high risk population
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 |
|---|---|---|---|
| ID-RCB | REGISTRY | 2024-A00552-45 | None |