Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease (NEURODEV-IPA)

Feasibility and efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children aged 1 to 5 with Congenital Heart Disease

Study Overview

• Status: Recruiting
• Conditions: Neurodevelopmental Disorders; Congenital Heart Disease in Children
• Intervention / Treatment: Other: Screening for neurodevelopmental disorders by an advanced practice nurse

Detailed Description

Congenital heart disease (CHD) is the leading cause of birth defects. Over 90% of children born with CHD reach adulthood. 50% of them will develop a neurodevelopmental disorder (NDD) that could affect life and long-term prognosis, including scholar and social integration and health related quality of life.

In France, there is a lack of medical resources to screen NDD in this population and to refer patients for appropriate and early treatment.

Investigators plan to propose a systematic early screening of NDD by an Advanced Practice Nurse (APN) during the usual cardiac follow-up. Children with CHD aged 1 to 5 will be included. If NDD is suspected, the patient will be referred to a neuropsychologist for NDD diagnosis confirmation and management planning. Patients with higher NDD risks (neonatal cardiac surgery) will benefit from a systematic neuropsychologist evaluation.

This study will investigate the feasibility and performance of an APN screening in this NDD-high risk population.

• Study Type: Interventional
• Enrollment (Estimated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie VINCENTI, MD; Phone Number: 04 67 33 66 39; Email: m-vincenti@chu-montpellier.fr
• Study Contact Backup: Name: Clinical Research Associate; Phone Number: 06 67 33 66 32; Email: recherche-clinique-ccp@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • University Hospitial of Montpellier
    • Contact: Marie VINCENTI, MD; Phone Number: 04 67 33 66 39; Email: m-vincenti@chu-montpellier.fr
  • Palavas-les-Flots, France, 34250
    • Not yet recruiting
    • Institut Marin Saint-Pierre
    • Contact: Sophie Guillaumont, MD
  • Pessac, France, 33600
    • Not yet recruiting
    • CHU Bordeaux Haut-Leveque
    • Contact: Pascal Amedro, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Screening for neurodevelopmental disorders by an advanced practice nurse	Other: Screening for neurodevelopmental disorders by an advanced practice nurse; Screening for neurodevelopmental disorders by an advanced practice nurse with Ages & Stages Questionnaires (ASQ-3) and Haute Autorité de Santé (HAS) identification scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the IPA screening for NDD	This rate will be calculated by dividing the complete IPA screenings (including HAS and the ASQ-3 parent's questionnaire) and children coming to the Complex Congenital Heart Defects consultation during the study period.	18 months
Performance (sensibility) of the IPA screening for NDD on the NDD high risk population	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)
Performance (specificity) of the IPA screening for NDD on the NDD high risk population	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)
Performance (positive predictive value) of the IPA screening for NDD on the NDD high risk population	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)
Performance (negative predictive value) of the IPA screening for NDD on the NDD high risk population	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)
Prevalence of NDD in the high risk population		18 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: May 17, 2024
• First Submitted That Met QC Criteria: May 25, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: congenital heart disease; neuropsychological assessment; organization of care; advanced practice nurse; neurodevelopmental screening
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Mental Disorders; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Heart Defects, Congenital; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Diagnostic Services; Health Surveys; Surveys and Questionnaires; Public Health Practice; Mass Screening
• Other Study ID Numbers: RECHMPL21_0291; ID-RCB (Other Identifier: 2025-A02239-40)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No