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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'C535584', 'term': 'Cardiomyopathy, infantile histiocytoid'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2026-02-20', 'studyFirstSubmitQcDate': '2026-02-20', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'descriptive analysis', 'timeFrame': 'At inclusion , day one', 'description': 'Number of children having a pathological score at the SDQ questionnaire : score comprised between 17 and 40'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['congenital cardiopathy', 'children', 'cardiopulmonary bypass', 'extracorporeal circulation', 'congenital heart disease', 'early cardiac surgery', 'pediatric cardiac surgery', 'neurodevelopmental outcome'], 'conditions': ['Congenital Cardiomyopathy']}, 'descriptionModule': {'briefSummary': '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.\n\nAfter 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.', 'detailedDescription': '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.\n\nThe 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.\n\nDescriptive 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.\n\nQualitative 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.\n\nCollected 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Newborns with congenital heart disease who did not undergo surgical correction within the first three months of life\n* Newborns with congenital heart disease associated with an identified chromosomal or genetic abnormality'}, 'identificationModule': {'nctId': 'NCT07437261', 'acronym': 'NEUROTECH', 'briefTitle': 'Neuropsychomotor Development From Ages 6 to 18 in Children With Early Surgically Treated Congenital Heart Disease', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'RC31/24/0515'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Parents of Congenital Cardiopathy children operated', 'description': '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.', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Parents of Congenital Cardiopathy children operated']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Marseille', 'country': 'France', 'facility': 'APH Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'UH Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}