Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Screening for neurodevelopmental disorders by an advanced practice nurse.
- Who it may be relevant to
- Registry conditions: Congenital Heart Disease in Children, Neurodevelopmental Disorders. Basic parameters: 1 year — 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Screening for neurodevelopmental disorders by an advanced practice nurse
Screening for neurodevelopmental disorders by an advanced practice nurse with Ages \& Stages Questionnaires (ASQ-3) and Haute Autorité de Santé (HAS) identification scale
Primary outcome measures
- Sensibility of the IPA screening for neurodevelopmental disorder (NDD) on the whole population studied [Time frame: 4 months (to obtain the neurophysiologist assessment)]
Secondary outcome measures (6)
- Feasibility of the IPA screening for NDD [Time frame: 18 months]
- Performance (sensibility) of the IPA screening for NDD on the NDD high risk population [Time frame: 4 months (to obtain the neurophysiologist assessment)]
- Performance (specificity) of the IPA screening for NDD on the NDD high risk population [Time frame: 4 months (to obtain the neurophysiologist assessment)]
- Performance (positive predictive value) of the IPA screening for NDD on the NDD high risk population [Time frame: 4 months (to obtain the neurophysiologist assessment)]
- Performance (negative predictive value) of the IPA screening for NDD on the NDD high risk population [Time frame: 4 months (to obtain the neurophysiologist assessment)]
- Prevalence of NDD in the high risk population [Time frame: 18 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 3 centers
- University Hospitial of Montpellier — Montpellier
- Institut Marin Saint-Pierre — Palavas-les-Flots
- CHU Bordeaux Haut-Lévêque — Pessac
Identifiers
NCT: NCT06431269 · RECHMPL21_0291 · ID-RCB