NCT06431269

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started May 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
May 2024Jun 2028

First Submitted

Initial submission to the registry

May 17, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 28, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

May 31, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

September 25, 2025

Status Verified

June 1, 2025

Enrollment Period

4 years

First QC Date

May 17, 2024

Last Update Submit

September 24, 2025

Conditions

Congenital Heart Disease in ChildrenNeurodevelopmental Disorders

Keywords

congenital heart diseaseneurodevelopmental screeningadvanced practice nurseorganization of careneuropsychological assessment

Outcome Measures

Primary Outcomes (1)

  • Sensibility of the IPA screening for neurodevelopmental disorder (NDD) on the whole population studied

    This will be evaluated by comparing the results of the IPA screening (using both HAS scale and ASQ-3 parent's questionnaire) with results of the advanced neuropsychologist assessment. A positive IPA screening is defined by a NDD alert using the HAS scale and/or the ASQ-3 parent's questionnaire. The advanced neuropsychologist assessment will be done only for patients with CHD with a positive IPA screening.

    4 months (to obtain the neurophysiologist assessment)

Secondary Outcomes (6)

  • Feasibility of the IPA screening for NDD

    18 months

  • Performance (sensibility) of the IPA screening for NDD on the NDD high risk population

    4 months (to obtain the neurophysiologist assessment)

  • Performance (specificity) of the IPA screening for NDD on the NDD high risk population

    4 months (to obtain the neurophysiologist assessment)

  • Performance (positive predictive value) of the IPA screening for NDD on the NDD high risk population

    4 months (to obtain the neurophysiologist assessment)

  • Performance (negative predictive value) of the IPA screening for NDD on the NDD high risk population

    4 months (to obtain the neurophysiologist assessment)

  • +1 more secondary outcomes

Study Arms (1)

Screening for neurodevelopmental disorders by an advanced practice nurse

EXPERIMENTAL
Other: Screening for neurodevelopmental disorders by an advanced practice nurse

Interventions

Screening for neurodevelopmental disorders by an advanced practice nurseOTHER

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

Screening for neurodevelopmental disorders by an advanced practice nurse

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Hospitial of Montpellier

Montpellier, 34295, France

RECRUITING

Institut Marin Saint-Pierre

Palavas-les-Flots, 34250, France

NOT YET RECRUITING

CHU Bordeaux Haut-Lévêque

Pessac, 33600, France

NOT YET RECRUITING

MeSH Terms

Conditions

Neurodevelopmental DisordersHeart Defects, Congenital

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Mental DisordersCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Central Study Contacts

Marie VINCENTI, MD

CONTACT

04 67 33 66 39m-vincenti@chu-montpellier.fr

Clinical Research Associate

CONTACT

06 67 33 66 32recherche-clinique-ccp@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2024

First Posted

May 28, 2024

Study Start

May 31, 2024

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

September 25, 2025

Record last verified: 2025-06

Locations

FR(3)