An observational study in Heart Disease Congenital and Neurodevelopmental Disorder, sponsored by Nantes University Hospital. Recruiting at 8 sites in France. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Nantes University Hospital · Observational
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.
991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.
This study's planned enrollment of 450 is above the median of 119 across 440 observational studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →Nantes University Hospital is the lead sponsor of 839 studies on the registry; 195 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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:
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.
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)
Assessment of developmental delays through administration of the Bayley-4 test by a neuropsychologist
The samples to be collected at delivery will include: * A 4 ml maternal blood sample in an EDTA tube for lipidomic and metabolomic analyses at delivery * A 6 ml maternal blood sample in an EDTA tube (2 tubes of 3 ml) for genetic analysis * 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 * Samples from fresh placenta for transcriptomic, epigenetic, metabolomic, and lipidomic analyses * A meconium sample collected as soon as possible after birth in a dry tube for microbiome analysis During hospitalization for the cardiac surgery: * 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. * Perioperative neurobiomarker samples will be collected (one EDTA tube of 500 μL preoperatively and postoperatively on Day 1 and 2). At 1 month, a stool sample will be collected from the infants for microbiome analysis.
Questionnaire on diet and lifestyle during pregnancy (only for the mother)
The IES-R is a 22-item self-report measure (for DSM-IV) that assesses subjective distress caused by traumatic events.
* Cardiovascular follow-up data collection * Developmental follow-up data collection * Collection of postoperative brain MRI data, scheduled between Day 5 post-surgery and the end of the hospital stay * Collection of data on pregnancy exposure, obstetric events, and delivery data. * Collection of fetal ultrasound data (T2 and T3). * Collection of fetal echocardiography data (T2 and T3).
Evaluate the prevalence of developmental delays in infants with a critical congenital heart defect (CHD) at 6 months of age.
Time frame: 6 months
Evaluate the prevalence of developmental delay in infants with congenital heart defects (CHD) based on the type of heart defect.
Time frame: 6 months
Assess the presence of developmental delay in infants with CHD based on the complexity of cardiac surgery.
Time frame: 6 months
Evaluate and describe affected developmental domains.
Time frame: 6 months
Identify rare genetic variants associated with developmental delays in CHD patients through genome-wide analysis.
Time frame: 6 months
Identify common genetic variants associated with developmental delays in CHD patients through genome-wide analysis.
Time frame: 6 months
Characterize placental anatomopathological anomalies in CHD and their correlation with developmental delay at 6 months.
Time frame: 6 months
Determine maternal dietary habits during the third trimester, their correlation with placental anomalies, and developmental delay at 6 months.
Time frame: 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
Time frame: 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
Time frame: 6 months
Characterize neonatal microbiota and its association with developmental delay at 6 months.
Time frame: 6 months
Identify perioperative determinants of developmental delay in CHD.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Aug 2028, 42 months after the start.
Of 178 non-industry observational studies under Heart Defects, Congenital, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 83. This study's planned 42 months is close to that.
Counting every sponsor, half of 185 studies reached it within 44 months; a quarter within 17 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
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