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

NCT07437261 | Completed

• 1 other identifier: RC31/24/0515
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 2

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.

Conditions

Congenital Cardiomyopathy

Keywords

congenital cardiopathy; children; cardiopulmonary bypass; extracorporeal circulation; congenital heart disease; early cardiac surgery; pediatric cardiac surgery; neurodevelopmental outcome

Outcome Measures

Primary Outcomes (1)

• descriptive analysis

  Number of children having a pathological score at the SDQ questionnaire : score comprised between 17 and 40

  At inclusion , day one

Study Arms (1)

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.

Other: Questionnaire

Interventions

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.

Parents of Congenital Cardiopathy children operated

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (2)

APH Marseille

Marseille, France

Location

UH Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Cardiomyopathy, infantile histiocytoid; Heart Defects, Congenital

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start: February 8, 2025
• Primary Completion: February 8, 2026
• Study Completion: February 8, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)