Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-01-05 @ 5:40 PM
Study NCT ID:
NCT06442592
Status:
RECRUITING
Last Update Posted:
2024-12-24
First Post:
2024-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization and Support for Neurodevelopmental Disorders Associated with Congenital Heart Defects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}], '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'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1206}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-08-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2024-05-29', 'studyFirstSubmitQcDate': '2024-05-29', 'lastUpdatePostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the prevalence of neurodevelopmental disorders in children aged 3-11 years with critical congenital heart defects.', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'Identify rare genetic variants associated with genome-wide neurodevelopmental disorders in patients with congenital heart defects.', 'timeFrame': 'One day', 'description': 'The presence of rare genetic variants associated with neurodevelopmental disorders will be determined by a 30X whole genome sequencing approach based on the association study of congenital heart defects with neurodevelopmental disorders versus congenital heart defects without neurodevelopmental disorders.'}, {'measure': 'Identify frequent genetic variants associated with genome-wide neurodevelopmental disorders in patients with congenital heart defects.', 'timeFrame': 'One day', 'description': 'The presence of frequent genetic variants associated with neurodevelopmental disorders will be determined by a 30X whole genome sequencing approach based on the association study of congenital heart defects with neurodevelopmental disorders versus congenital heart defects without neurodevelopmental disorders.'}, {'measure': 'Assessment of the prevalence of neurodevelopmental disorders in children with critical congenital heart defects in each age subgroup (3-5, 6-8, and 9-11 years).', 'timeFrame': 'up to 14 days'}, {'measure': 'Evaluate and describe the neurodevelopmental domains affected in the pediatric population of Nantes.', 'timeFrame': 'up to 14 days', 'description': 'Functional diagnosis of different types of NDD defined by at least one score deficient in relation to the test norm (-1.5 standard deviation or 90 percentile) in each age subgroup.'}, {'measure': 'Assessment of the quality of life and psychopathological aspects of the child as well as parental stress.', 'timeFrame': 'up to 14 days', 'description': 'Proportion of children with impaired quality of life, psychopathological difficulties and proportion of adults with parental stress, compared with the test norm (-1.5 standard deviation or 90 percentile).'}, {'measure': 'Assessment of diagnostic accuracy (of NDD) provided by an innovative multidisciplinary approach.', 'timeFrame': 'up to 14 days', 'description': 'Comparison of TND frequency in Nantes versus associated centers and description of differences between centers'}, {'measure': 'Describe the different types of neurodevelopmental disorders (number and nature of neurodevelopmental domains affected) in each age subgroup (intelligence, oral language, motor skills, school learning, executive functions, social interactions).', 'timeFrame': 'up to 14 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Congenital Heart Defects', 'Neurodevelopmental Disorder', 'Genetics'], 'conditions': ['Congenital Heart Defects', 'Neurodevelopmental Disorder']}, 'descriptionModule': {'briefSummary': "The leading cause of birth defects, Congenital Heart Defects (CHD) affect 12 million people worldwide and 41,000 newborns/year in Europe. It's a major cause of life-long morbidity and mortality, and a crucial public health issue. More than 50% of childs born with critical CHD will develop Neurodevelopmental Disorders (NDs), requiring specific care and impairing quality of life. NDs corresponds to early and lasting disturbances in cognitive, affective and behavioral development, linked to abnormalities in brain development. They are heterogeneous, affecting language, learning, motor skills, intellectual efficiency, social cognition, attention, memory and executive functions, and are associated with psychosocial difficulties (adaptive behavior, social interactions). This hidden handicap is the main long-term sequels of CHD, even before cardiovascular sequels, in individuals who often underwent multiple heart operations in early childhood. NDs concern not only complex CHD, but also simple CHD repaired in childhood and considered cured.\n\nThe origin of TND associated with CHD is largely unknown. To date, few genetic or environmental causes have been clearly identified, but recent work has suggested that a common origin may link cardiac malformation and neurodevelopmental abnormality.\n\nThe CATAMARAN - Pediatrics project is designed to detect potential neurodevelopmental delays associated with CHD as early as age 3, and to identify individual susceptibility factors involved in the occurrence of NDs in CHD children."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Child (aged 3 to 11) with critical MCC operated on for heart surgery during the first three months of life\n* Parents and child affiliated with or benefiting from a social security or similar scheme\n* Parents' and child's good understanding of the French language\n* Free, informed and written consent of both parents for themselves and for the child\n* Free, informed and written consent of the child aged 6 and over\n* Biological parents\n\nExclusion Criteria:\n\n* Genetic anomaly or malformative syndrome associated with neurodevelopmental abnormalities, identified prior to inclusion\n* Neurodevelopmental assessment not practicable"}, 'identificationModule': {'nctId': 'NCT06442592', 'acronym': 'CATAMARAN Ped', 'briefTitle': 'Characterization and Support for Neurodevelopmental Disorders Associated with Congenital Heart Defects', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'CATAMARAN - Pediatrics : Characterization and Support for Neurodevelopmental Disorders Associated with Congenital Heart Defects', 'orgStudyIdInfo': {'id': 'RC23_0548'}, 'secondaryIdInfos': [{'id': '2024-A00428-39', 'type': 'OTHER', 'domain': 'ANSM (IDRCB)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'CATAMARAN - Pediatrics - Nantes', 'description': 'The study population will consist of 201 children aged 3 to 11 and their two parents.', 'interventionNames': ['Other: Blood sampling', 'Diagnostic Test: Assessment of neurodevelopment (Nantes)', 'Other: Assessment of the parental stress']}, {'type': 'OTHER', 'label': 'CATAMARAN - Pediatrics - Associated centers (excluding Nantes)', 'description': 'The study population will consist of 201 children aged 3 to 11 and their two parents.', 'interventionNames': ['Other: Blood sampling', 'Diagnostic Test: Assessment of neurodevelopment (CA)', 'Other: Assessment of the parental stress']}], 'interventions': [{'name': 'Blood sampling', 'type': 'OTHER', 'description': 'An EDTA blood sample will be taken from the children and their two parents. Sample volume will be 2 x 3mL.', 'armGroupLabels': ['CATAMARAN - Pediatrics - Associated centers (excluding Nantes)', 'CATAMARAN - Pediatrics - Nantes']}, {'name': 'Assessment of neurodevelopment (CA)', 'type': 'DIAGNOSTIC_TEST', 'description': 'The children will be seen by a neuropsychologist, who will then determine whether or not they have neurodevelopmental disorders.', 'armGroupLabels': ['CATAMARAN - Pediatrics - Associated centers (excluding Nantes)']}, {'name': 'Assessment of neurodevelopment (Nantes)', 'type': 'DIAGNOSTIC_TEST', 'description': 'The children will be seen by a multidisciplinary team (including a neuropsychologist), who will then determine whether or not they have neurodevelopmental disorders.', 'armGroupLabels': ['CATAMARAN - Pediatrics - Nantes']}, {'name': 'Assessment of the parental stress', 'type': 'OTHER', 'description': "Parents' parental stress will be assessed using the Parental Stress Index (PSI) questionnaire.", 'armGroupLabels': ['CATAMARAN - Pediatrics - Associated centers (excluding Nantes)', 'CATAMARAN - Pediatrics - Nantes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29200', 'city': 'Brest', 'state': 'Brittany Region', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Guillaume DEVERRIERE', 'role': 'CONTACT', 'email': 'Guillaume.deverriere@chu-brest.fr'}, {'name': 'Guillaume DEVERRIERE', 'role': 'CONTACT'}], 'facility': 'Chu Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '35000', 'city': 'Rennes', 'state': 'Brittany Region', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Clémence Le Seven', 'role': 'CONTACT'}], 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '44000', 'city': 'Nantes', 'state': 'Loire-Atlantique', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alban Baruteau', 'role': 'CONTACT', 'email': 'albanelouen.baruteau@chu-nantes.fr', 'phone': '02 40 08 77 42'}, {'name': 'Alban Baruteau', 'role': 'CONTACT'}], 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '49000', 'city': 'Angers', 'state': 'Maine-et-Loire', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Anne-Sophie Lety', 'role': 'CONTACT'}], 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '37000', 'city': 'Tours', 'state': 'Val de Loire', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Bruno Lefort', 'role': 'CONTACT'}], 'facility': 'CHU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Alban Baruteau', 'role': 'CONTACT', 'email': 'albanelouen.baruteau@chu-nantes.fr', 'phone': '02 40 08 77 42'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Angers - Pays de la Loire psychology laboratory', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}