Clinical trial NCT03360370: Neurodevelopmental Disorders in Children With Congenital Heart Disease
Official title: Screening for Neurodevelopmental Disorders in Children With Congenital Heart Disease Aged From 6 to 66 Months in Nord-Pas-de-Calais
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Keywords: Neurodevelopmental disorders,
Congenital heart disease
Children
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 233
Sex: ALL
Minimum age (years): 6
Maximum age (years): 66
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children With Congenital Heart Disease

Brief summary: Children with congenital heart disease are at risk for neurodevelopmental disorders, these disorders impacting their quality of life and their integration into society.

The aim of this study is to detect neurodevelopmental disorders in children (aged from 6 to 66 months) with congenital heart disease in Nord-Pas-De-Calais (France) and to evaluate the frequency and risk factors of these neurodevelopmental disorders for a better follow-up.

This study will help implementing a specific program for the evaluation and management of neurodevelopmental disorders in children suffering from congenital heart disease in Nord-Pas-De-Calais and more globally, in the region Hauts-De-France.

Detailed description: Are selected children with "significant" congenital heart disease (aged from 6 to 66 months) in "Nord-Pas-De-Calais" fulfilling inclusion criteria. A reliable and valid questionnaire used to screen developmental delays of children aged from one month to 66 months is completed by volunteer parents at the time of the study. Data of the questionnaire is collected and a scoring by professional is provided ; children at risk for neurodevelopmental delays are depicted.

In parallel, medical and surgical history is also collected to detect risk factors for neurodevelopmental disorders.

The frequency of neurodevelopmental disorders in this screened population according to risk factors (among neonatal data, severity of congenital heart disease, surgery, length of stay at hospital,... ) will be evaluated. The ratio children with neurodevelopmental disorders for whom specific care was implemented/ children with neurodevelopmental disorders who did not have specific care despite neurodevelopmental disorders will be established.

Follow-up action will be taken for children at risk for developping neurological disorders highlighted by the screening.

This study will help implementing a specific program for evaluation and management of neurodevelopmental disorders for children with congenital heart disease in our region.

Eligibility criteria: Inclusion Criteria:

* Children aged 6 to 66 months at the time of study
* living in region "Nord-Pas-De-Calais"
* with " significant" congenital heart disease (= complex congenital heart diseases operated or not, simple or moderate congenital heart disease who had cardiac surgery)
* Followed by the Pediatric Cardiology Department of Lille University Hospital, or patients having a cardiopediatric follow-up outside Lille University Hospital but having been taken in charge at the University Hospital of Lille for any reason (cardiac or not)

Exclusion Criteria:

Children :

* lost to sight
* Deceased
* with congenital heart disease, living in Nord-Pas-de-Calais but never having been taken in charge at Lille University Hospital
* with mild or moderate congenital heart disease not having undergone surgery or having only undergone cardiac catheterization
* with cardiac surgery not performed in the Centers of Jacques CARTIER and Marie LANNNELONGUE

Primary outcomes:
measure: Percentage of children classified "at risk" for neuro-developmental disorders by the Age & Stage Questionnaire Third Edition in French (ASQ3) score
timeFrame: Baseline: one session
Secondary outcomes:
measure: Frequency of neurodevelopmental disorders in children with congenital heart disease in this screened population
timeFrame: Baseline: one session
measure: Frequency of neurodevelopmental disorders according to the severity of congenital heart disease
timeFrame: Baseline: one session
measure: Number of Children With Documented Risk Factors for neurodevelopmental disorders
timeFrame: Baseline: one session
measure: Ratio of children with neurodevelopmental disorders and for whom specific care was implemented
timeFrame: Baseline: one session
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Jeanne de Flandres, CHU
Study officials:
affiliation: University Hospital, Lille
name: Marie-Paule GUILLAUME, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Billotte M, Deken V, Joriot S, Vaksmann G, Richard A, Bouzguenda I, Godart F, Baudelet JB, Rakza T, Nguyen The Tich S, Guillaume MP. Screening for neurodevelopmental disorders in children with congenital heart disease. Eur J Pediatr. 2021 Apr;180(4):1157-1167. doi: 10.1007/s00431-020-03850-x. Epub 2020 Oct 29.