Neurodevelopmental Disorders in Children With Congenital Heart Disease

NCT03360370 | Completed

• 2 other identifiers: 2017_312017-A01839-44.
• Study Type: observational
• Target: 233
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

Neurodevelopmental disorders,; Congenital heart disease; Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Frequency of neurodevelopmental disorders in children with congenital heart disease in this screened population

  Baseline: one session

• Frequency of neurodevelopmental disorders according to the severity of congenital heart disease

  Baseline: one session

• Number of Children With Documented Risk Factors for neurodevelopmental disorders

  Baseline: one session

• Ratio of children with neurodevelopmental disorders and for whom specific care was implemented

  Baseline: one session

Study Arms (1)

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™)

Interventions

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

6 to 66 months children with significant CHD

Eligibility Criteria

• Age: 6 Months - 66 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children With Congenital Heart Disease

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Jeanne de Flandres, CHU

Lille, France

Location

Related Publications (1)

• 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.

  PMID: 33119792 RESULT

MeSH Terms

Conditions

Heart Defects, Congenital; Neurodevelopmental Disorders

Interventions

Glycation End Products, Advanced

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mental Disorders

Intervention Hierarchy (Ancestors)

Glycoconjugates; Carbohydrates; Toxins, Biological; Biological Factors

Study Officials

• Marie-Paule GUILLAUME, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 4, 2017
• Study Start: December 6, 2017
• Primary Completion: June 6, 2018
• Study Completion: June 6, 2018
• Last Updated: May 14, 2026

Record last verified: 2018-08

Locations

FR (1)