Neurodevelopmental Disorders in Children With Congenital Heart Disease

NCT ID: NCT03360370

Last Updated: 2018-08-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 233 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-06
• Study Completion Date: 2018-06-06

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.

Conditions

Congenital Heart Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

6 to 66 months children with significant CHD

Children with "significant" congenital heart disease (CHD) aged from 6 to 66 months at the time of the study and fulfilling inclusion criteria for whom an age-appropriate questionnaire completed by parents (Ages \& Stages Questionnaires, Third Edition in French (ASQ-3™) will be used to screen developmental delays.

Ages & Stages Questionnaires, Third Edition in French (ASQ-3™)

Intervention Type: OTHER

This questionnaire screens 5 neurodevelopmental areas (communication, gross motor, fine motor, problem solving and personal-social); 30 items per questionnaire about the child's abilities are evaluated.

It takes about 15-20 minutes. Data are collecting and a scoring by a professional is provided. Follow-up action is taken for children at risk. Medical and surgical history is also collected to detect risk factors for neurodevelopmental disorders among neonatal data, characteristics of congenital heart disease and first surgery, and other comorbidities.

Interventions

Ages & Stages Questionnaires, Third Edition in French (ASQ-3™)

This questionnaire screens 5 neurodevelopmental areas (communication, gross motor, fine motor, problem solving and personal-social); 30 items per questionnaire about the child's abilities are evaluated.

It takes about 15-20 minutes. Data are collecting and a scoring by a professional is provided. Follow-up action is taken for children at risk. Medical and surgical history is also collected to detect risk factors for neurodevelopmental disorders among neonatal data, characteristics of congenital heart disease and first surgery, and other comorbidities.

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 66 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie-Paule GUILLAUME, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Hôpital Jeanne de Flandres, CHU

Lille, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 33119792 (View on PubMed)

Other Identifiers

2017-A01839-44.

Identifier Type: OTHER

Identifier Source: secondary_id

2017_31

Identifier Type: -

Identifier Source: org_study_id