Congenital CardiomyopathyNEUROTECHNCT07437261
Neuropsychomotor Development From Ages 6 to 18 in Children With Early Surgically Treated Congenital Heart Disease
An observational study of Congenital Cardiomyopathy, run by University Hospital, Toulouse at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Congenital Cardiomyopathy
- What is being tested?
- Questionnaire
- How many people
- 155 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Feb 2025to 8 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 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.
Who may be able to join
- parents of children survivors between 6 and 18 years old who underwent surgical correction of congenital heart disease with cardiopulmonary bypass during the first three months of life between january 1st 2006 and 31st of December 2018.
Who cannot join
- Newborns with congenital heart disease who did not undergo surgical correction within the first three months of life
- Newborns with congenital heart disease associated with an identified chromosomal or genetic abnormality
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Congenital Cardiomyopathy
- Being tested
- Questionnaire
- Keywords
- congenital cardiopathy, children, cardiopulmonary bypass, extracorporeal circulation, congenital heart disease, early cardiac surgery, pediatric cardiac surgery, neurodevelopmental outcome
- Medical subject headings
- Cardiomyopathy, infantile histiocytoid, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Parents of Congenital Cardiopathy children operated | 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. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
descriptive analysis
Number of children having a pathological score at the SDQ questionnaire : score comprised between 17 and 40
Measured: At inclusion , day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start8 Feb 2025
- Primary completion8 Feb 2026
- Study completion8 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital CardiomyopathyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437261
- Sponsor's protocol ID
- RC31/24/0515
- Acronym
- NEUROTECH
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07437261
- Acronym / sponsor ID
- NEUROTECH / RC31/24/0515
- Conditions
- Congenital Cardiomyopathy
- Keywords
- congenital cardiopathy, children, cardiopulmonary bypass, extracorporeal circulation, congenital heart disease, early cardiac surgery, pediatric cardiac surgery, neurodevelopmental outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 8 Feb 2025 (actual)
- Primary completion
- 8 Feb 2026 (actual)
- Study completion
- 8 Feb 2026 (actual)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parents of Congenital Cardiopathy children operated | – | Other: QuestionnaireThe 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- parents of children survivors between 6 and 18 years old who underwent surgical correction of congenital heart disease with cardiopulmonary bypass during the first three months of life between january 1st 2006 and 31st of December 2018.
Key exclusion criteria (2 listed)
- Newborns with congenital heart disease who did not undergo surgical correction within the first three months of life
- Newborns with congenital heart disease associated with an identified chromosomal or genetic abnormality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireThe 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. | Other | Parents of Congenital Cardiopathy children operated |
Primary outcome
descriptive analysis
Time frame: At inclusion , day one
Number of children having a pathological score at the SDQ questionnaire : score comprised between 17 and 40
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Cardiomyopathy, run by University Hospital, Toulouse at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
descriptive analysis (time frame: At inclusion , day one). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.