Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease

NCT ID: NCT06431269

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2028-06-30

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.

Conditions

Congenital Heart Disease in Children; Neurodevelopmental Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Screening for neurodevelopmental disorders by an advanced practice nurse

Group Type: EXPERIMENTAL

Screening for neurodevelopmental disorders by an advanced practice nurse

Intervention Type: OTHER

Screening for neurodevelopmental disorders by an advanced practice nurse with Ages \& Stages Questionnaires (ASQ-3) and Haute Autorité de Santé (HAS) identification scale

Interventions

Screening for neurodevelopmental disorders by an advanced practice nurse

Screening for neurodevelopmental disorders by an advanced practice nurse with Ages \& Stages Questionnaires (ASQ-3) and Haute Autorité de Santé (HAS) identification scale

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Congenital heart disease with stable status defined by last operation >3 months, no cardiac decompensation in the last 3 months, no planned surgery within 6 months after the inclusion
• Cardiac surgery and/or catheter-based cardiac intervention(s) during the first year of life,
• Patient aged 1 to 5 years.
• No previous medical diagnosis of NDD
• Parental or legal guardian's consent.
• Social security affiliation (for France only)

Exclusion Criteria

• Patients with a genetic or poly-malformative syndrome with known neurological impairment.
• Neurodevelopmental disorder already known/treated
• Neurodevelopmental status evaluation within the last 6 months.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospitial of Montpellier

Montpellier, , France

Site Status: RECRUITING

Institut Marin Saint-Pierre

Palavas-les-Flots, , France

Site Status: NOT_YET_RECRUITING

CHU Bordeaux Haut-Lévêque

Pessac, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Marie VINCENTI, MD

Role: CONTACT

m-vincenti@chu-montpellier.fr

04 67 33 66 39

Clinical Research Associate

Role: CONTACT

recherche-clinique-ccp@chu-montpellier.fr

06 67 33 66 32

Facility Contacts

Marie VINCENTI, MD

Role: primary

m-vincenti@chu-montpellier.fr

04 67 33 66 39

Sophie Guillaumont, MD

Role: primary

Pascal Amedro, MD

Role: primary

Other Identifiers

ID-RCB

Identifier Type: REGISTRY

Identifier Source: secondary_id

RECHMPL21_0291

Identifier Type: -

Identifier Source: org_study_id