Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Congenital Heart Disease in Children
- Sponsor
- University Hospital, Montpellier
- Enrollment
- 270
- Locations
- 3
- Primary Endpoint
- Sensibility of the IPA screening for neurodevelopmental disorder (NDD) on the whole population studied
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
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.
Investigators
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
- •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.
Outcomes
Primary Outcomes
Sensibility of the IPA screening for neurodevelopmental disorder (NDD) on the whole population studied
Time Frame: 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 Outcomes
- Performance (negative predictive value) of the IPA screening for NDD on the NDD high risk population(4 months (to obtain the neurophysiologist assessment))
- Prevalence of NDD in the high risk population(18 months)
- Feasibility of the IPA screening for NDD(18 months)
- Performance (sensibility) of the IPA screening for NDD on the NDD high risk population(4 months (to obtain the neurophysiologist assessment))
- Performance (specificity) of the IPA screening for NDD on the NDD high risk population(4 months (to obtain the neurophysiologist assessment))
- Performance (positive predictive value) of the IPA screening for NDD on the NDD high risk population(4 months (to obtain the neurophysiologist assessment))