Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-31 @ 2:39 AM
Study NCT ID:
NCT06690151
Status:
RECRUITING
Last Update Posted:
2025-09-08
First Post:
2024-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac malfoRmations - Neonatal
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': 'D003625', 'term': 'Data Collection'}, {'id': 'D001775', 'term': 'Blood Circulation'}, {'id': 'D011295', 'term': 'Prenatal Care'}, {'id': 'D011247', 'term': 'Pregnancy'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'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'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008427', 'term': 'Maternal Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D012098', 'term': 'Reproduction'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '* Infant blood sample\n* Infant stool collection\n* Paternal blood sample\n* Maternal blood sample\n* Umbilical cord venous blood sample\n* Meconium'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-08-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-01', 'studyFirstSubmitDate': '2024-11-13', 'studyFirstSubmitQcDate': '2024-11-13', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the prevalence of developmental delays in infants with a critical congenital heart defect (CHD) at 6 months of age.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Evaluate the prevalence of developmental delay in infants with congenital heart defects (CHD) based on the type of heart defect.', 'timeFrame': '6 months'}, {'measure': 'Assess the presence of developmental delay in infants with CHD based on the complexity of cardiac surgery.', 'timeFrame': '6 months'}, {'measure': 'Evaluate and describe affected developmental domains.', 'timeFrame': '6 months'}, {'measure': 'Identify rare genetic variants associated with developmental delays in CHD patients through genome-wide analysis.', 'timeFrame': '6 months'}, {'measure': 'Identify common genetic variants associated with developmental delays in CHD patients through genome-wide analysis.', 'timeFrame': '6 months'}, {'measure': 'Characterize placental anatomopathological anomalies in CHD and their correlation with developmental delay at 6 months.', 'timeFrame': '6 months'}, {'measure': 'Determine maternal dietary habits during the third trimester, their correlation with placental anomalies, and developmental delay at 6 months.', 'timeFrame': '6 months'}, {'measure': 'Characterize maternal behavioral exposures (e.g., tobacco, alcohol, drugs) and obstetric complications (e.g., hypertension, preeclampsia, gestational diabetes) during pregnancy, and their correlation with placental anomalies and developmental delay', 'timeFrame': '6 months'}, {'measure': 'Characterize antenatal determinants of developmental delay through multi-omics analysis (metabolomics, lipidomics, transcriptomics, and epigenetics) of maternal blood, placental function, and fetal blood, and their correlation with developmental delay', 'timeFrame': '6 months'}, {'measure': 'Characterize neonatal microbiota and its association with developmental delay at 6 months.', 'timeFrame': '6 months'}, {'measure': 'Identify perioperative determinants of developmental delay in CHD.', 'timeFrame': '6 months'}, {'measure': 'Identify optimal perfusion pressure targets during and after neonatal cardiac surgery under cardiopulmonary bypass in three participating centers using continuous analysis of invasive blood pressure and cerebral oxygen saturation', 'timeFrame': 'up to 3 months'}, {'measure': 'For CHU Nantes patients only: identify fetal neuronal biomarkers at birth, track their evolution before and after cardiac surgery in CHD infants, and establish associations with developmental delay at 6 months.', 'timeFrame': '6 months'}, {'measure': 'Evaluate parental post-traumatic stress at 1) antenatal inclusion, 2) perioperative period, and 3) 6 months post-surgery, and its correlation with developmental delay at 6 months.', 'timeFrame': '6 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Congenital heart defects (CHD)', 'neurodevelopmental disorders (NDD)', 'genetics'], 'conditions': ['Heart Disease Congenital', 'Neurodevelopmental Disorder']}, 'descriptionModule': {'briefSummary': "Congenital heart defects (CHD), as the leading cause of birth defects, affect 12 million people globally and approximately 41,000 newborns each year in Europe. CHD presents a significant public health concern due to its association with high morbidity and mortality rates across the lifespan. Over 50% of infants born with critical CHD will develop neurodevelopmental disorders (NDD), requiring specialized care and impacting their quality of life. NDDs, involving early and persistent disruptions in cognitive, emotional, and behavioral development due to abnormal brain development, are highly variable. They may impact language, learning, motor skills, intellectual efficiency, social cognition, attention, memory, and executive functions, often accompanied by psychosocial difficulties. These hidden disabilities constitute the primary long-term sequelae of CHD, surpassing even cardiovascular complications in impact, and affect children who often undergo multiple cardiac surgeries during early childhood. NDDs are associated not only with complex CHDs but also with simpler CHDs that are repaired in early childhood and considered 'cured.'\n\nThe origin of CHD-associated NDDs remains largely unknown. While few genetic or environmental causes have been identified, recent research suggests a possible common origin linking heart malformations and neurodevelopmental abnormalities. The CATAMARAN neonatal cohort project aims to detect developmental delays associated with CHD as early as six months of age and to identify both individual susceptibility factors and acquired vulnerabilities contributing to the development of NDDs in infants with CHD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will focus on the inclusion of 150 fetuses with a prenatally diagnosed critical congenital heart defect (CHD), at high risk of developing developmental delays, and their two parents.', 'healthyVolunteers': False, 'eligibilityCriteria': "The inclusion criteria are as follows:\n\n* Fetus with a congenital heart defect (CHD) detected prenatally (prenatal diagnosis of the heart defect)\n* Fetus with a critical CHD defined as requiring cardiac surgery during the first three months of the infant's life\n* Parents affiliated with or beneficiaries of a social security or equivalent system\n* Parents' good understanding of the French language\n* Voluntary, informed, and written consent from both parents for themselves and the unborn child\n\nCriteria for parents\\*:\n\n\\- Biological parents \\*The inclusion of the father in the project does not limit the participation of the child (patient) in the study.\n\n\\*The father will be encouraged to participate in the project by providing a blood sample to create a trio (mother/father/infant) for future genetic analyses.\n\nHowever, if the father is unavailable or does not consent to the collection and storage of samples for analysis (as part of the CATAMARAN study or future research projects related to biobanking), the child can still be included in the study.\n\nExclusion Criteria:\n\n* Medical termination of pregnancy considered\n* Genetic anomaly or malformative syndrome identified prior to inclusion"}, 'identificationModule': {'nctId': 'NCT06690151', 'acronym': 'CATAMARAN - NN', 'briefTitle': 'Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac malfoRmations - Neonatal', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'CATAMARAN - Neonatal Cohort : Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac malfoRmations - Neonatal', 'orgStudyIdInfo': {'id': 'RC23_0547'}, 'secondaryIdInfos': [{'id': 'IDRCB (ANSm) : 2024-A00425-42', 'type': 'OTHER', 'domain': 'Agence nationale de sécurité du médicament et des produits de santé (ANSM)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study population (Newborns with congenital heart defects and their two parents)', 'description': 'The study population will consist of 150 fetuses with a prenatally diagnosed critical congenital heart defect (CHD), at high risk of developing developmental delays, and their two parents.', 'interventionNames': ['Behavioral: Neurodevelopmental assessment (Bayley-IV)', 'Other: Biological sampling', 'Behavioral: ELFE dietary questionnaire', 'Behavioral: Post-Traumatic Stress Questionnaire IES-R (Impact of Event Scale - Revised)', 'Other: Data collection for the study (Cardiovascular, developemental, fetal, pregnancy, MRI)']}], 'interventions': [{'name': 'Neurodevelopmental assessment (Bayley-IV)', 'type': 'BEHAVIORAL', 'description': 'Assessment of developmental delays through administration of the Bayley-4 test by a neuropsychologist', 'armGroupLabels': ['Study population (Newborns with congenital heart defects and their two parents)']}, {'name': 'Biological sampling', 'type': 'OTHER', 'description': 'The samples to be collected at delivery will include:\n\n* A 4 ml maternal blood sample in an EDTA tube for lipidomic and metabolomic analyses at delivery\n* A 6 ml maternal blood sample in an EDTA tube (2 tubes of 3 ml) for genetic analysis\n* A 4 ml venous cord blood sample in an EDTA tube for transcriptomic and epigenetic analysis; and a 2 ml EDTA tube for metabolomic/lipidomic analysis\n* Samples from fresh placenta for transcriptomic, epigenetic, metabolomic, and lipidomic analyses\n* A meconium sample collected as soon as possible after birth in a dry tube for microbiome analysis\n\nDuring hospitalization for the cardiac surgery:\n\n* Genome analysis samples will be collected from the father and the infant. These samples will be taken in two EDTA tubes of 3 ml each.\n* Perioperative neurobiomarker samples will be collected (one EDTA tube of 500 μL preoperatively and postoperatively on Day 1 and 2).\n\nAt 1 month, a stool sample will be collected from the infants for microbiome analysis.', 'armGroupLabels': ['Study population (Newborns with congenital heart defects and their two parents)']}, {'name': 'ELFE dietary questionnaire', 'type': 'BEHAVIORAL', 'description': 'Questionnaire on diet and lifestyle during pregnancy (only for the mother)', 'armGroupLabels': ['Study population (Newborns with congenital heart defects and their two parents)']}, {'name': 'Post-Traumatic Stress Questionnaire IES-R (Impact of Event Scale - Revised)', 'type': 'BEHAVIORAL', 'description': 'The IES-R is a 22-item self-report measure (for DSM-IV) that assesses subjective distress caused by traumatic events.', 'armGroupLabels': ['Study population (Newborns with congenital heart defects and their two parents)']}, {'name': 'Data collection for the study (Cardiovascular, developemental, fetal, pregnancy, MRI)', 'type': 'OTHER', 'description': '* Cardiovascular follow-up data collection\n* Developmental follow-up data collection\n* Collection of postoperative brain MRI data, scheduled between Day 5 post-surgery and the end of the hospital stay\n* Collection of data on pregnancy exposure, obstetric events, and delivery data.\n* Collection of fetal ultrasound data (T2 and T3).\n* Collection of fetal echocardiography data (T2 and T3).', 'armGroupLabels': ['Study population (Newborns with congenital heart defects and their two parents)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'state': 'Loire Atlantique', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alban BARUTEAU', 'role': 'CONTACT', 'email': 'albanelouen.baruteau@chu-nantes.fr', 'phone': '+33 253482835'}, {'name': 'Alban BARUTEAU', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nantes University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Marseille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Caroline OVAERT', 'role': 'CONTACT', 'email': 'caroline.ovaert@ap-hm.fr', 'phone': '+334 91386496'}, {'name': 'Caroline OVAERT', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'AP-HM', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Tours', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Franck PERROTIN', 'role': 'CONTACT', 'email': 'franck.perrotin@univ-tours.fr', 'phone': '+33 248484848'}, {'name': 'Franck PERROTIN', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHRU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'centralContacts': [{'name': 'Alban Baruteau', 'role': 'CONTACT', 'email': 'albanelouen.baruteau@chu-nantes.fr', 'phone': '+33 2 40 08 77 42'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pays de la Loire Laboratory of Psychology (LPPL)', 'class': 'UNKNOWN'}, {'name': 'Physiopathology of Nutritional Adaptations Joint Research Unit (UMR PhAN)', 'class': 'UNKNOWN'}, {'name': 'Institut du thorax, INSERM UMR1087', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}