Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease
- Conditions
- Congenital Heart Disease in ChildrenNeurodevelopmental Disorders
- Interventions
- Other: Screening for neurodevelopmental disorders by an advanced practice nurse
- Registration Number
- NCT06431269
- Lead Sponsor
- University Hospital, Montpellier
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 270
- 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)
- Genetic or poly-malformative syndrome with usual neurodevelopmental care (CAMPS-type care network)
- Neurodevelopmental status evaluation within the last 6 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Screening for neurodevelopmental disorders by an advanced practice nurse Screening for neurodevelopmental disorders by an advanced practice nurse -
- Primary Outcome Measures
Name Time Method Sensibility of the IPA screening for neurodevelopmental disorder (NDD) on the whole population studied 4 months (to obtain the neurophysiologist assessment) 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 Outcome Measures
Name Time Method Performance (negative predictive value) of the IPA screening for NDD on the NDD high risk population 4 months (to obtain the neurophysiologist assessment) 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.
Prevalence of NDD in the high risk population 18 months Feasibility of the IPA screening for NDD 18 months 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 4 months (to obtain the neurophysiologist assessment) 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 4 months (to obtain the neurophysiologist assessment) 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 4 months (to obtain the neurophysiologist assessment) 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.
Trial Locations
- Locations (3)
University Hospitial of Montpellier
🇫🇷Montpellier, France
Institut Marin Saint-Pierre
🇫🇷Palavas-les-Flots, France
CHU Bordeaux Haut-Lévêque
🇫🇷Pessac, France