Screening for neurodevelopmental disorders in children with congenital heart disease
Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease
This study tests if regular check-ups can help find neurodevelopmental disorders in young children with congenital heart disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 1 Year to 5 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 3 sites (Montpellier and 2 other locations) |
| Trial ID | NCT06431269 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the feasibility and efficiency of screening for neurodevelopmental disorders (NDD) in children aged 1 to 5 years who have congenital heart disease (CHD). An Advanced Practice Nurse (APN) will conduct systematic screenings during routine cardiac follow-ups. If NDD is suspected, children will be referred to a neuropsychologist for further evaluation and management. The study addresses the gap in medical resources for early NDD detection in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 to 5 years with stable congenital heart disease and no prior diagnosis of neurodevelopmental disorders.
Not a fit: Patients with genetic or poly-malformative syndromes requiring specialized neurodevelopmental care may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier diagnosis and management of neurodevelopmental disorders in children with congenital heart disease, improving their long-term quality of life.
How similar studies have performed: While similar approaches have been explored, this specific method of screening by an Advanced Practice Nurse in this population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Montpellier and 2 other locations
- University Hospitial of Montpellier — Montpellier, France (Recruiting)
- Institut Marin Saint-Pierre — Palavas-les-Flots, France (Not_yet_recruiting)
- CHU Bordeaux Haut-Lévêque — Pessac, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Marie VINCENTI, MD
- Email: m-vincenti@chu-montpellier.fr
- Phone: 04 67 33 66 39
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.