Clinical trial NCT06431269: Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease
Official title: Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital Heart Disease in Children
Neurodevelopmental Disorders
Keywords: congenital heart disease
neurodevelopmental screening
advanced practice nurse
organization of care
neuropsychological assessment
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 270
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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.

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:

* Genetic or poly-malformative syndrome with usual neurodevelopmental care (CAMPS-type care network)
* Neurodevelopmental status evaluation within the last 6 months.

Primary outcomes:
measure: Sensibility of the IPA screening for neurodevelopmental disorder (NDD) on the whole population studied
timeFrame: 4 months (to obtain the neurophysiologist assessment)
Secondary outcomes:
measure: Feasibility of the IPA screening for NDD
timeFrame: 18 months
measure: Performance (sensibility) of the IPA screening for NDD on the NDD high risk population
timeFrame: 4 months (to obtain the neurophysiologist assessment)
measure: Performance (specificity) of the IPA screening for NDD on the NDD high risk population
timeFrame: 4 months (to obtain the neurophysiologist assessment)
measure: Performance (positive predictive value) of the IPA screening for NDD on the NDD high risk population
timeFrame: 4 months (to obtain the neurophysiologist assessment)
measure: Performance (negative predictive value) of the IPA screening for NDD on the NDD high risk population
timeFrame: 4 months (to obtain the neurophysiologist assessment)
measure: Prevalence of NDD in the high risk population
timeFrame: 18 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospitial of Montpellier
city: Palavas-les-Flots
country: France
facility: Institut Marin Saint-Pierre
city: Pessac
country: France
facility: CHU Bordeaux Haut-Lévêque
Study officials:
References: