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

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ClinicalTrials.gov Identifier: NCT03360370
Recruitment Status : Not yet recruiting
First Posted : December 4, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Congenital Heart Disease 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 Design

Study Type : Observational
Estimated Enrollment : 233 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening for Neurodevelopmental Disorders in Children With Congenital Heart Disease Aged From 6 to 66 Months in Nord-Pas-de-Calais
Anticipated Study Start Date : December 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

Groups and Cohorts

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.



Outcome Measures

Primary Outcome Measures :
  1. Percentage of children classified "at risk" for neuro-developmental disorders by the Age & Stage Questionnaire Third Edition in French (ASQ3) score [ Time Frame: Baseline: one session ]
    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).


Secondary Outcome Measures :
  1. Frequency of neurodevelopmental disorders in children with congenital heart disease in this screened population [ Time Frame: Baseline: one session ]
    Number of children depicted with neurodevelopmental delays in comparison to children who do not have neurodevelopmental delays in the screened population

  2. Frequency of neurodevelopmental disorders according to the severity of congenital heart disease [ Time Frame: Baseline: one session ]
    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.

  3. Number of Children With Documented Risk Factors for neurodevelopmental disorders [ Time Frame: Baseline: one session ]
    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

  4. Ratio of children with neurodevelopmental disorders and for whom specific care was implemented [ Time Frame: Baseline: one session ]
    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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 66 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children With Congenital Heart Disease
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360370


Contacts
Contact: Marie-Paule GUILLAUME, MD 3 20 44 69 49 ext +33 Marie-Paule.Guillaume@CHRU-lille.fr

Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Marie-Paule GUILLAUME, MD University Hospital, Lille
More Information

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03360370     History of Changes
Other Study ID Numbers: 2017_31
2017-A01839-44. ( Other Identifier: ID-RCB number, ANSM )
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
Neurodevelopmental disorders,
Congenital heart disease
Children

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Neurodevelopmental Disorders
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Mental Disorders