An observational study in Congenital Cardiomyopathy, sponsored by University Hospital, Toulouse. Completed at 2 sites in France. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by University Hospital, Toulouse · Observational
This study will invite parents of children who underwent surgical treatment for congenital heart disease to complete a validated proxy-report questionnaire assessing executive and psychosocial functioning. The instrument used will be the French version of the Strengths and Difficulties Questionnaire (SDQ), validated for children aged 6-17 years, which evaluates cognitive, executive, and mental health domains and provides both global and subdomain scores.
After a telephone explanation, the questionnaire will be sent to parents of eligible children aged 6-18 years and returned by post once completed. This methodology is modeled on follow-up networks for vulnerable newborns, where parent-completed questionnaires are completed at home and mailed back.
This study will invite parents of children previously hospitalized for surgical treatment of congenital heart disease to complete a validated proxy-report questionnaire assessing executive and psychosocial development.
The instrument used will be the French version of the Strengths and Difficulties Questionnaire (SDQ), known as the "Questionnaire Points Forts - Points Faibles". The Strengths and Difficulties Questionnaire is a validated screening tool for children aged 6-17 years. It evaluates emotional symptoms, behavioral problems, hyperactivity/inattention, peer relationship difficulties, and prosocial behavior. The questionnaire provides a global score categorized as "normal," "borderline," or "abnormal," with the "abnormal" threshold corresponding to approximately the 10th percentile of the most impaired segment of the reference population. Each subdomain also yields a specific score, allowing more precise characterization of the type of difficulty identified.
Descriptive statistical analyses will be performed using conventional methods. Quantitative variables will be described using a measure of central tendency (mean or median) and dispersion (standard deviation or interquartile range), depending on data distribution. Statistical testing will follow a two-sided approach with a significance level of 5%. Student's t-test will be used for normally distributed variables meeting application criteria; otherwise, the non-parametric Wilcoxon-Mann-Whitney test will be applied.
Qualitative variables will be expressed as percentages with 95% confidence intervals. Group comparisons will be conducted using the chi-square test (when expected counts exceed 5) or Fisher's exact test, as appropriate. For secondary objectives, multivariate analysis will be performed using logistic regression models constructed based on bivariate results and relevant literature.
Collected variables will include demographic, perinatal, surgical, and postoperative data: sex; gestational age; prematurity; birth weight, length, and head circumference; intrauterine growth restriction; Apgar scores at 1, 5, and 10 minutes; type of congenital heart disease; age at surgery; duration of cardiopulmonary bypass and aortic cross-clamping; need for transfusion; delayed sternal closure; postoperative lactate levels; cardiac arrest; need for ECMO; postoperative pulmonary hypertension; duration of vasoactive support; hemorrhagic shock; dialysis; reoperation; duration of invasive ventilation; ventilator-associated pneumonia; mediastinitis; sepsis; endocarditis; seizures; pre- and postoperative EEG abnormalities; transient or persistent neurological abnormalities at discharge; length of ICU stay, standard hospitalization, and total hospitalization; post-discharge rehabilitation (physiotherapy, psychomotor therapy, speech therapy) and their duration; as well as total and subdomain SDQ scores.
1,006 studies on the registry are indexed under Heart Defects, Congenital; 256 are open to participants now.
This study's enrollment of 155 is above the median of 120 across 441 observational studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.
Counted across the registry records on this site, refreshed daily.
parents of children survivors between 6 and 18 years old who underwent surgical correction of congenital heart disease with cardiopulmonary bypass at CHU of Toulouse or of Marseille during the first three months of life between january 1st 2006 and 31st of December 2018.
Exclusion Criteria:
The cohort concentrates on children from the Pediatric Intensive Care Units of CHU de Toulouse and CHU de Marseille between 2006 and 2018. Eligible participants are parents of survivors who underwent surgical correction of congenital heart disease with cardiopulmonary bypass during the first three months of life. They will complete the SDQ questionnaire.
Other: Questionnaire
The instrument used is the French version of the Strengths and Difficulties Questionnaire (SDQ), known as the "Questionnaire Points Forts - Points Faibles". The Strengths and Difficulties Questionnaire is a validated screening tool for children aged 6-17 years. It evaluates emotional symptoms, behavioral problems, hyperactivity/inattention, peer relationship difficulties, and prosocial behavior. The questionnaire provides a global score categorized as "normal," "borderline," or "abnormal," with the "abnormal" threshold corresponding to approximately the 10th percentile of the most impaired segment of the reference population. Each subdomain also yields a specific score, allowing more precise characterization of the type of difficulty identified.
descriptive analysis
Number of children having a pathological score at the SDQ questionnaire : score comprised between 17 and 40
Time frame: At inclusion , day one
Plan to share: No
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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Cardiomyopathy, infantile histiocytoid
University Hospital, Toulouse