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Search / Trial NCT06431269

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

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · May 25, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Congenital Heart Disease Neurodevelopmental Screening Advanced Practice Nurse Organization Of Care Neuropsychological Assessment

ClinConnect Summary

This clinical trial is looking at how well an advanced practice nurse can screen young children, ages 1 to 5, with congenital heart disease for neurodevelopmental disorders (NDDs). Neurodevelopmental disorders can affect a child's learning, behavior, and overall development. The study aims to see if this type of screening is practical and efficient, which could help identify any concerns early on so that families can get the right support.

To participate in this trial, children must have stable congenital heart disease, meaning they have not had any recent heart problems or surgeries. They should not have been previously diagnosed with any neurodevelopmental disorders and must have parental or guardian consent to take part. Families can expect a supportive environment where the nurse will conduct screenings to check for developmental issues. This trial is currently recruiting participants, and it's an important step towards better understanding and managing the developmental health of children with heart conditions.

Gender

ALL

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.

About University Hospital, Montpellier

The University Hospital of Montpellier is a leading academic medical institution dedicated to advancing healthcare through innovative research and clinical trials. Renowned for its commitment to patient-centered care, the hospital collaborates with multidisciplinary teams to explore cutting-edge treatments and therapies across various medical fields. By integrating clinical practice with education and research, the University Hospital of Montpellier aims to enhance health outcomes and contribute to the scientific community's understanding of complex medical conditions. Its robust infrastructure and expertise make it a pivotal player in the landscape of clinical research.

Locations

Montpellier, , France

Palavas Les Flots, , France

Pessac, , France

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported