NCT03360370

Neurodevelopmental Disorders in Children With Congenital Heart Disease

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 233 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 6 Months – 66 Months
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-12-06
• Primary completion: 2018-06-06
• Completion: 2018-06-06
• First posted: 2017-12-04
• Last updated: 2018-08-02

Locations

1 site across 1 country: France