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| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB (ANSm) : 2024-A00425-42 | Other Identifier | Agence nationale de sécurité du médicament et des produits de santé (ANSM) |
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| Name | Class |
|---|---|
| Pays de la Loire Laboratory of Psychology (LPPL) | UNKNOWN |
| Physiopathology of Nutritional Adaptations Joint Research Unit (UMR PhAN) | UNKNOWN |
| Institut du thorax, INSERM UMR1087 | UNKNOWN |
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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.'
The 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study population (Newborns with congenital heart defects and their two parents) | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurodevelopmental assessment (Bayley-IV) | Behavioral | Assessment of developmental delays through administration of the Bayley-4 test by a neuropsychologist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the prevalence of developmental delays in infants with a critical congenital heart defect (CHD) at 6 months of age. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the prevalence of developmental delay in infants with congenital heart defects (CHD) based on the type of heart defect. | 6 months | |
| Assess the presence of developmental delay in infants with CHD based on the complexity of cardiac surgery. | 6 months |
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The inclusion criteria are as follows:
Criteria for parents*:
- Biological parents *The inclusion of the father in the project does not limit the participation of the child (patient) in the study.
*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.
However, 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.
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alban Baruteau | Contact | +33 2 40 08 77 42 | albanelouen.baruteau@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes University Hospital | Recruiting | Nantes | Loire Atlantique | 44093 | France |
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| Biological sampling | Other | The samples to be collected at delivery will include:
During hospitalization for the cardiac surgery:
At 1 month, a stool sample will be collected from the infants for microbiome analysis. |
|
| ELFE dietary questionnaire | Behavioral | Questionnaire on diet and lifestyle during pregnancy (only for the mother) |
|
| Post-Traumatic Stress Questionnaire IES-R (Impact of Event Scale - Revised) | Behavioral | The IES-R is a 22-item self-report measure (for DSM-IV) that assesses subjective distress caused by traumatic events. |
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| Data collection for the study (Cardiovascular, developemental, fetal, pregnancy, MRI) | Other |
|
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| Evaluate and describe affected developmental domains. | 6 months |
| Identify rare genetic variants associated with developmental delays in CHD patients through genome-wide analysis. | 6 months |
| Identify common genetic variants associated with developmental delays in CHD patients through genome-wide analysis. | 6 months |
| Characterize placental anatomopathological anomalies in CHD and their correlation with developmental delay at 6 months. | 6 months |
| Determine maternal dietary habits during the third trimester, their correlation with placental anomalies, and developmental delay at 6 months. | 6 months |
| 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 | 6 months |
| 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 | 6 months |
| Characterize neonatal microbiota and its association with developmental delay at 6 months. | 6 months |
| Identify perioperative determinants of developmental delay in CHD. | 6 months |
| 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 | up to 3 months |
| 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. | 6 months |
| 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. | 6 months |
| CHU de Bordeaux | Recruiting | Bordeaux | France |
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| APHP - Antoine Béclère | Recruiting | Clamart | 92140 | France |
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| Hôpital Marie Lannelongue | Recruiting | Le Plessis-Robinson | 92350 | France |
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| AP-HM | Recruiting | Marseille | France |
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| AP-HP Necker | Not yet recruiting | Paris | France |
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| CHU de Toulouse | Not yet recruiting | Toulouse | 31000 | France |
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| CHRU Tours | Recruiting | Tours | France |
|
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D065886 | Neurodevelopmental Disorders |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| D001775 | Blood Circulation |
| D011295 | Prenatal Care |
| D011247 | Pregnancy |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D008427 | Maternal Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D012098 | Reproduction |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
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