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Completed

NCT Number: NCT07437261

Neuropsychomotor Development From Ages 6 to 18 in Children With Early Surgically Treated Congenital Heart Disease

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.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

APH Marseille, Marseille, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Questionnaire

Other

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study 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

Acronym: NEUROTECH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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