Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:21 AM
Study NCT ID:
NCT07437261
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2026-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuropsychomotor Development From Ages 6 to 18 in Children With Early Surgically Treated Congenital Heart Disease
Sponsor:
University Hospital, Toulouse
Organization:
Study Overview
Official Title:
Evaluation of Neuropsychomotor Development Between Six and Eighteen Years of Age in Children With a History of Congenital Heart Disease Operated Under Extracorporeal Circulation Before Three Months of Life
Status:
COMPLETED
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEUROTECH
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: