Neurodevelopmental Disorders Clinical Trial
— NEURODEV-IPAOfficial title:
Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease
Feasibility and efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children aged 1 to 5 with Congenital Heart Disease
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. |
Country | Name | City | State |
---|---|---|---|
France | University Hospitial of Montpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
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 |
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