Neurodevelopmental Disorders in Children With Congenital Heart Disease (NeuroDis-CHD)

Screening for Neurodevelopmental Disorders in Children With Congenital Heart Disease Aged From 6 to 66 Months in Nord-Pas-de-Calais

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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease
• Intervention / Treatment: Other: Ages & Stages Questionnaires, Third Edition in French (ASQ-3™)

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.

• Study Type: Observational
• Enrollment (Actual): 233

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital Jeanne de Flandres, CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children With Congenital Heart Disease

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of children classified "at risk" for neuro-developmental disorders by the Age & Stage Questionnaire Third Edition in French (ASQ3) score	The ASQ3 evaluates neurodevelopment in children by a parental questionnaire. ASQ-3 score screens 5 neurodevelopmental areas (communication, gross motor, fine motor, problem solving and personal-social); 30 items per questionnaire about the child's skills are evaluated. Each item could be range between Yes (The child do the action - 10 points), Sometimes (5 points) or Not yet (0 point). The scale for each areas could be from 0 (worse outcome) to 60 points (best outcome). The different areas scores are referred in a chart specific of each questionnaire. In each area the score indicates if the child's development appears to be on schedule (best outcome), need learning and attention or need to be evaluated by a professional (worse outcome, - 2 SD from the global population).	Baseline: one session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of neurodevelopmental disorders in children with congenital heart disease in this screened population	Number of children depicted with neurodevelopmental delays in comparison to children who do not have neurodevelopmental delays in the screened population	Baseline: one session
Frequency of neurodevelopmental disorders according to the severity of congenital heart disease	Children with neurodevelopmental disorders are classified according to the severity of the congenital heart disease ( mild, moderate or severe congenital heart disease). The percentage of children with neurodevelopmental disorders in each category is established and compared to the others.	Baseline: one session
Number of Children With Documented Risk Factors for neurodevelopmental disorders	The number of children with documented risk factors for neurodevelopmental disorders among neonatal data characteristics of congenital heart disease and first surgery, and comorbidities is evaluated	Baseline: one session
Ratio of children with neurodevelopmental disorders and for whom specific care was implemented	The ratio of children with neurodevelopmental disorders for whom specific care was implemented /children with neurodevelopmental disorders who do not have specific care despite neurodevelopmental disorders is established	Baseline: one session

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Marie-Paule GUILLAUME, MD, University Hospital, Lille

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2017
• Primary Completion (Actual): June 6, 2018
• Study Completion (Actual): June 6, 2018

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (Actual): December 4, 2017

Study Record Updates

• Last Update Posted (Actual): August 2, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Children; Congenital heart disease; Neurodevelopmental disorders,
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital; Neurodevelopmental Disorders
• Other Study ID Numbers: 2017_31; 2017-A01839-44. (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No