Neurodevelopmental Disorders in Children With Congenital Heart Disease

Congenital Heart Disease Clinical Trial

— NeuroDis-CHD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03360370
• Other study ID #: 2017_31
• Secondary ID: 2017-A01839-44.
• Status: Completed
• Start date: December 6, 2017
• Est. completion date: June 6, 2018

Study information

• Verified date: August 2018
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: June 6, 2018
• Est. primary completion date: June 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 66 Months

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Neurodevelopmental Disorders

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Jeanne de Flandres, CHU	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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