CATAMARAN - Neonatal Cohort : Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac malfoRmations - Neonatal
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 9
- 主要终点
- Evaluate the prevalence of developmental delays in infants with a critical congenital heart defect (CHD) at 6 months of age.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria are as follows:
- •Fetus with a congenital heart defect (CHD) detected prenatally (prenatal diagnosis of the heart defect)
- •Fetus with a critical CHD defined as requiring cardiac surgery during the first three months of the infant's life
- •Parents affiliated with or beneficiaries of a social security or equivalent system
- •Parents' good understanding of the French language
- •Voluntary, informed, and written consent from both parents for themselves and the unborn child
- •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.
排除标准
- •Medical termination of pregnancy considered
- •Genetic anomaly or malformative syndrome identified prior to inclusion
结局指标
主要结局
Evaluate the prevalence of developmental delays in infants with a critical congenital heart defect (CHD) at 6 months of age.
时间窗: 6 months
次要结局
- 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)
- 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)