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

Neurodevelopmental Disorders Clinical Trial

— NEURODEV-IPA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06431269
• Other study ID #: 21_0291
• Secondary ID: ID-RCB
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2026

Study information

• Verified date: May 2024
• Source: University Hospital, Montpellier
• Contact: Marie VINCENTI, MD
• Phone: 04 67 33 66 39
• Email: m-vincenti[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 270
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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:

• Genetic or poly-malformative syndrome with usual neurodevelopmental care (CAMPS-type care network)

• Neurodevelopmental status evaluation within the last 6 months.

Related Conditions & MeSH terms

• Congenital Heart Disease in Children
• Heart Defects, Congenital
• Heart Diseases
• Neurodevelopmental Disorders

Intervention

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

Locations

Country	Name	City	State
France	University Hospitial of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Prevalence of NDD in the high risk population		18 months