Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac malfoRmations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-28

Study Completion Date

2027-08-28

Brief Summary

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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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Detailed Description

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Conditions

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Heart Disease Congenital Neurodevelopmental Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Neurodevelopmental assessment (Bayley-IV)

Intervention Type BEHAVIORAL

Assessment of developmental delays through administration of the Bayley-4 test by a neuropsychologist

Biological sampling

Intervention Type OTHER

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.

ELFE dietary questionnaire

Intervention Type BEHAVIORAL

Questionnaire on diet and lifestyle during pregnancy (only for the mother)

Post-Traumatic Stress Questionnaire IES-R (Impact of Event Scale - Revised)

Intervention Type BEHAVIORAL

The IES-R is a 22-item self-report measure (for DSM-IV) that assesses subjective distress caused by traumatic events.

Data collection for the study (Cardiovascular, developemental, fetal, pregnancy, MRI)

Intervention Type OTHER

* 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).

Interventions

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Neurodevelopmental assessment (Bayley-IV)

Assessment of developmental delays through administration of the Bayley-4 test by a neuropsychologist

Intervention Type BEHAVIORAL

Biological sampling

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.

Intervention Type OTHER

ELFE dietary questionnaire

Questionnaire on diet and lifestyle during pregnancy (only for the mother)

Intervention Type BEHAVIORAL

Post-Traumatic Stress Questionnaire IES-R (Impact of Event Scale - Revised)

The IES-R is a 22-item self-report measure (for DSM-IV) that assesses subjective distress caused by traumatic events.

Intervention Type BEHAVIORAL

Data collection for the study (Cardiovascular, developemental, fetal, pregnancy, MRI)

* 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).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.