An observational study in Congenital Heart Disease, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 6 Months to 66 Months. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by University Hospital, Lille · Observational
Among 73 studies in Heart Defects, Congenital with a site in France — 19 open to participants now, 22 under way, none of them phase 3. Heart Defects, Congenital · France.
Among the 73 studies in Heart Defects, Congenital with a site in France, this one is the 23rd largest by enrollment of the 39 observational ones, is one of 5 that started in 2017, is one of 39 observational ones, and was the 20th registered.
991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.
This study's enrollment of 233 is above the median of 119 across 440 observational studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →19 of the 73 studies in Heart Defects, Congenital with a site in France are open now, in 12 countries. Each count lists the studies.
Of the 154 Heart Defects, Congenital studies recruiting now, 67 (44%) set no upper age limit and 79 (51%) stop at 75 or younger; 110 take children under 18; 25 take healthy volunteers.
This study: 6 Months to 66 Months · all sexes · no healthy volunteers.
The full table on the hub →73 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 5 started in 2017.
Median enrollment 91 across the 34 interventional studies, 300 across the 39 observational. Of the 39 that completed or were terminated, 5 (13%) have results posted.
9 of 73 have an industry lead sponsor. The 10 most frequent:
University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.
University Hospital, Lille has 1 study filed under Heart Defects, Congenital — fewer than ten, so there is no comparison to draw.
5 of the studies in Heart Defects, Congenital with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06823635Fondation Hôpital Saint-JosephAn International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects | 2026-12-31 |
| NCT04591392atHeart MedicalSafety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD | 2027-03 |
| NCT07864129University Hospital, Strasbourg, FranceVolution of Pulmonary Artery Dimensions in Tetralogy of Fallot | 2027-04-18 |
| NCT06998290University Hospital, BordeauxFeasibility of Home Telemonitoring of Infants With Congenital Heart Disease Awaiting Surgery During the First Year of Life | 2027-06-01 |
| NCT06442592Nantes University HospitalCharacterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects | 2027-07-08 |
Among the 73 studies in Heart Defects, Congenital with a site in France, from their registry updates:
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.
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.
Children With Congenital Heart Disease
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Children :
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.
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).
Time frame: Baseline: one session
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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Baseline: one session
Ran from Dec 2017 to primary completion in Jun 2018, 6 months.
Of 178 non-industry observational studies under Heart Defects, Congenital, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 83. This study's 6 months is below that.
Counting every sponsor, half of 185 studies reached it within 44 months; a quarter within 17 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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