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Recruiting NCT06431269

NCT06431269 Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease

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Clinical Trial Summary
NCT ID NCT06431269
Status Recruiting
Phase
Sponsor University Hospital, Montpellier
Condition Congenital Heart Disease in Children
Study Type INTERVENTIONAL
Enrollment 270 participants
Start Date 2024-05-31
Primary Completion 2028-06

Eligibility & Interventions

Sex All sexes
Min Age 1 Year
Max Age 5 Years
Study Type INTERVENTIONAL
Interventions
Screening for neurodevelopmental disorders by an advanced practice nurse

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 270 participants in total. It began in 2024-05-31 with a primary completion date of 2028-06.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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

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.

Contact & Investigator

Central Contact

Marie VINCENTI, MD

✉ m-vincenti@chu-montpellier.fr

📞 04 67 33 66 39

Frequently Asked Questions

Who can join the NCT06431269 clinical trial?

This trial is open to participants of all sexes, aged 1 Year or older, up to 5 Years, studying Congenital Heart Disease in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06431269 currently recruiting?

Yes, NCT06431269 is actively recruiting participants. Contact the research team at m-vincenti@chu-montpellier.fr for enrollment information.

Where is the NCT06431269 trial being conducted?

This trial is being conducted at Montpellier, France, Palavas-les-Flots, France, Pessac, France.

Who is sponsoring the NCT06431269 clinical trial?

NCT06431269 is sponsored by University Hospital, Montpellier. The trial plans to enroll 270 participants.

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