Actively Recruiting
Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease
Led by University Hospital, Montpellier · Updated on 2025-09-25
270
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility and effectiveness of screening for neurodevelopmental disorders (NDD) in children aged 1 to 5 years with congenital heart disease (CHD), a group at high risk for these conditions. This study aims to address a gap in early detection and referral for appropriate care, as over half of children with CHD may develop NDD that can impact their education, social integration, and quality of life. The research is sponsored by the University Hospital in Montpellier and focuses on improving early diagnosis and management in this vulnerable population. The study involves screening children with CHD during their routine cardiac follow-up visits using a screening performed by an Advanced Practice Nurse (APN). The screening uses tools such as the Ages & Stages Questionnaires (ASQ-3) and the Haute Autorité de Santé (HAS) identification scale. Children who show signs of possible NDD will be referred to a neuropsychologist for a detailed evaluation and care planning. Those at higher risk due to early cardiac surgery also receive systematic neuropsychological assessments. Participants will be monitored over several months, with the main outcome being the sensitivity of the APN screening to detect NDD confirmed by neuropsychologist assessments within four months. Additional outcomes include feasibility, performance measures like specificity and predictive values, and prevalence of NDD in high-risk children over an 18-month period. The study involves collecting screening results, neuropsychological evaluations, and following children’s neurodevelopment, aiming to improve early identification and intervention strategies.
CONDITIONS
Brief Title
Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 1 to 5 years
- Diagnosed with congenital heart disease with a stable status (no heart failure or planned surgery within 6 months)
- Had cardiac surgery or catheter-based cardiac intervention during the first year of life
- No previous medical diagnosis of neurodevelopmental disorder
- Parental or legal guardian consent obtained
- Affiliated with social security (for France only)
You will not qualify if you...
- Presence of genetic or multiple malformation syndromes with known neurological impairment
- Previously diagnosed or treated neurodevelopmental disorder
- Neurodevelopmental evaluation performed within the last 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 months
Participants undergo screening for neurodevelopmental disorders by an advanced practice nurse using standardized questionnaires and identification scales.
Screening occurs during usual cardiac follow-up visits
Duration - 18 months
Participants with suspected neurodevelopmental disorders are referred for neuropsychologist evaluation and management planning. Those at higher risk receive systematic neuropsychologist evaluation.
Follow-up assessments aligned with routine cardiac care visits
Trial Site Locations
Total: 3 locations
1
University Hospitial of Montpellier
Montpellier, France, 34295
Actively Recruiting
2
Institut Marin Saint-Pierre
Palavas-les-Flots, France, 34250
Not Yet Recruiting
3
CHU Bordeaux Haut-Lévêque
Pessac, France, 33600
Not Yet Recruiting
Research Team
M
Marie VINCENTI, MD
C
Clinical Research Associate
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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