About this trial
Feasibility and efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children aged 1 to 5 with Congenital Heart Disease
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Screening for neurodevelopmental disorders by an advanced practice nurse
Other interventionScreening for neurodevelopmental disorders by an advanced practice nurse with Ages \& Stages Questionnaires (ASQ-3) and Haute Autorité de Santé (HAS) identification scale
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.