Screening for neurodevelopmental disorders in children with congenital heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Understanding brain development in congenital hypothyroidism: comparing affected children, healthy controls, and mild thyroid conditions

  This study tests how brain development in children with congenital hypothyroidism compares to similar children without the condition and to kids with a mild thyroid finding.

  Recruiting at 3 sites Istituto Giannina Gaslini · Genova and 2 other locations · NCT07893522

• Leopard: using multi-omics to boost genetic diagnosis for neurodevelopmental disorders

  This study tests a multi-omics approach to find genetic explanations for neurodevelopmental disorders in people with moderate-to-severe intellectual disability.

  Recruiting Istituto Giannina Gaslini · Genova · NCT07884227

• Melillo Method for kids with behavior and learning challenges

  This pilot test will see if the Melillo Method can be feasibly delivered in two Illinois schools to help kids aged 8 and up who have behavioral and learning difficulties.

  Recruiting Life University · Roodhouse, Illinois · NCT07779889

• Understanding how sensory brain signals vary in people with and without neurodevelopmental disorders

  This study tests whether people with neurodevelopmental disorders show more variation in brain responses to sensory stimulation than people without these disorders.

  Recruiting University Hospital, Tours · Tours · NCT07542977

• Two-week intensive brain-focused therapy program for children with neurodevelopmental and chromosomal conditions

  This program will try a two-week, individualized multimodal neurorehabilitation approach for children about 4–12 years old with neurodevelopmental or chromosomal conditions to see if it improves attention, motor skills, communication, and daily functioning.

  Recruiting Healing Hope International · The Woodlands, Texas · NCT07493096

• Social cognition testing for 8–16-year-olds with autism, ADHD, or atypical development

  This project will test a multidimensional social-cognition battery in French-speaking 8–16-year-olds with autism, ADHD, or atypical neurodevelopment to see if it better identifies social processing differences.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris · NCT07439276

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.