Congenital Heart DefectsCATAMARAN PedNCT06442592
Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects
A study testing Blood sampling, Assessment of neurodevelopment (CA) and Assessment of neurodevelopment (Nantes) in people with Congenital Heart Defects and Neurodevelopmental Disorder, run by Nantes University Hospital at 5 sites in France.
Trial summary
The leading cause of birth defects, Congenital Heart Defects (CHD) affect 12 million people worldwide and 41,000 newborns/year in Europe. It's a major cause of life-long morbidity and mortality, and a crucial public health issue. Read more about this study
- Who is it for?
- Ages 3 to 11 years
- Conditions the study is for
- Congenital Heart Defects, Neurodevelopmental Disorder
- What is being tested?
- Blood sampling, Assessment of neurodevelopment (CA) and Assessment of neurodevelopment (Nantes)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,206 participants
- Where
- 5 sitesFrance
- Study dates
- 8 Jul 2024to 8 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child (aged 3 to 11) with critical MCC operated on for heart surgery during the first three months of life
- Parents and child affiliated with or benefiting from a social security or similar scheme
- Parents' and child's good understanding of the French language
- Free, informed and written consent of both parents for themselves and for the child
- Free, informed and written consent of the child aged 6 and over
- Biological parents
Who cannot join
- Genetic anomaly or malformative syndrome associated with neurodevelopmental abnormalities, identified prior to inclusion
- Neurodevelopmental assessment not practicable
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
CHU Angers
Angers, Maine-et-Loire, 49000
Anne-Sophie Lety
- Recruiting
Chu Brest
Brest, Brittany Region, 29200
Guillaume DEVERRIERE, Guillaume.deverriere@chu-brest.fr
Guillaume DEVERRIERE
- Recruiting
CHU Nantes
Nantes, Loire-Atlantique, 44000
Alban Baruteau, 02 40 08 77 42, albanelouen.baruteau@chu-nantes.fr
Alban Baruteau
- Recruiting
CHU Rennes
Rennes, Brittany Region, 35000
Clémence Le Seven
- Recruiting
CHU Tours
Tours, Val de Loire, 37000
Bruno Lefort
About this study
Official title: CATAMARAN - Pediatrics : Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects
The leading cause of birth defects, Congenital Heart Defects (CHD) affect 12 million people worldwide and 41,000 newborns/year in Europe. It's a major cause of life-long morbidity and mortality, and a crucial public health issue. More than 50% of childs born with critical CHD will develop Neurodevelopmental Disorders (NDs), requiring specific care and impairing quality of life. NDs corresponds to early and lasting disturbances in cognitive, affective and behavioral development, linked to abnormalities in brain development. They are heterogeneous, affecting language, learning, motor skills, intellectual efficiency, social cognition, attention, memory and executive functions, and are associated with psychosocial difficulties (adaptive behavior, social interactions). This hidden handicap is the main long-term sequels of CHD, even before cardiovascular sequels, in individuals who often underwent multiple heart operations in early childhood. NDs concern not only complex CHD, but also simple CHD repaired in childhood and considered cured.
The origin of TND associated with CHD is largely unknown. To date, few genetic or environmental causes have been clearly identified, but recent work has suggested that a common origin may link cardiac malformation and neurodevelopmental abnormality.
The CATAMARAN - Pediatrics project is designed to detect potential neurodevelopmental delays associated with CHD as early as age 3, and to identify individual susceptibility factors involved in the occurrence of NDs in CHD children.
- Being tested
- Blood sampling, Assessment of neurodevelopment (CA), Assessment of neurodevelopment (Nantes), Assessment of the parental stress
- Keywords
- Congenital Heart Defects, Neurodevelopmental Disorder, Genetics
- Medical subject headings
- Heart Defects, Congenital, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
An EDTA blood sample will be taken from the children and their two parents. Sample volume will be 2 x 3mL.
Assessment of neurodevelopment (CA)Diagnostic test
The children will be seen by a neuropsychologist, who will then determine whether or not they have neurodevelopmental disorders.
Assessment of neurodevelopment (Nantes)Diagnostic test
The children will be seen by a multidisciplinary team (including a neuropsychologist), who will then determine whether or not they have neurodevelopmental disorders.
Assessment of the parental stressOther
Parents' parental stress will be assessed using the Parental Stress Index (PSI) questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| CATAMARAN - Pediatrics - Interdisciplinary programme - Nantes Only | Other | The study population will consist of 201 children aged 3 to 11 and their two parents. Receives: Other: Blood sampling; Diagnostic Test: Assessment of neurodevelopment (Nantes); Other: Assessment of the parental stress |
| CATAMARAN - Pediatrics - Unique neuropsychological assessment Associated centers (including Nantes) | Other | The study population will consist of 201 children aged 3 to 11 and their two parents. Receives: Other: Blood sampling; Diagnostic Test: Assessment of neurodevelopment (CA); Other: Assessment of the parental stress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the prevalence of neurodevelopmental disorders in children aged 3-11 years with critical congenital heart defects.
Measured: 14 days
Secondary outcomes (7)
Identify rare genetic variants associated with genome-wide neurodevelopmental disorders in patients with congenital heart defects.
The presence of rare genetic variants associated with neurodevelopmental disorders will be determined by a 30X whole genome sequencing approach based on the association study of congenital heart defects with neurodevelopmental disorders versus congenital heart defects without neurodevelopmental disorders.
Measured: One day
Identify frequent genetic variants associated with genome-wide neurodevelopmental disorders in patients with congenital heart defects.
The presence of frequent genetic variants associated with neurodevelopmental disorders will be determined by a 30X whole genome sequencing approach based on the association study of congenital heart defects with neurodevelopmental disorders versus congenital heart defects without neurodevelopmental disorders.
Measured: One day
Assessment of the prevalence of neurodevelopmental disorders in children with critical congenital heart defects in each age subgroup (3-5, 6-8, and 9-11 years).
Measured: up to 14 days
Evaluate and describe the neurodevelopmental domains affected in the pediatric population of Nantes (Multidisciplinary assessment).
Functional diagnosis of different types of NDD defined by at least one score deficient in relation to the test norm (-1.5 standard deviation or 90 percentile) in each age subgroup.
Measured: up to 14 days
Assessment of the quality of life and psychopathological aspects of the child as well as parental stress.
Proportion of children with impaired quality of life, psychopathological difficulties and proportion of adults with parental stress, compared with the test norm (-1.5 standard deviation or 90 percentile).
Measured: up to 14 days
Assessment of diagnostic accuracy (of NDD) provided by an innovative multidisciplinary approach.
Comparison of TND frequency in Nantes versus associated centers and description of differences between centers
Measured: up to 14 days
Describe the different types of neurodevelopmental disorders (number and nature of neurodevelopmental domains affected) in each age subgroup (intelligence, oral language, motor skills, school learning, executive functions, social interactions).
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start8 Jul 2024
- Primary completion8 Jul 2027 (estimated)
- Study completion8 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DefectsStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Angers University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442592
- Sponsor's protocol ID
- RC23_0548
- Other IDs
- 2024-A00428-39
- Acronym
- CATAMARAN Ped
- Status last verified
- Mar 2026
- First submitted
- 29 May 2024
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CATAMARAN - Pediatrics : Characterization and Support for Neurodevelopmental Disorders Associated With Congenital Heart Defects
- ClinicalTrials.gov ID
- NCT06442592
- Acronym / sponsor ID
- CATAMARAN Ped / RC23_0548
- Keywords
- Congenital Heart Defects, Neurodevelopmental Disorder, Genetics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,206 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Angers University
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 8 Jul 2027 (estimated)
- Study completion
- 8 Aug 2027 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The leading cause of birth defects, Congenital Heart Defects (CHD) affect 12 million people worldwide and 41,000 newborns/year in Europe. It's a major cause of life-long morbidity and mortality, and a crucial public health issue. More than 50% of childs born with critical CHD will develop Neurodevelopmental Disorders (NDs), requiring specific care and impairing quality of life. NDs corresponds to early and lasting disturbances in cognitive, affective and behavioral development, linked to abnormalities in brain development. They are heterogeneous, affecting language, learning, motor skills, intellectual efficiency, social cognition, attention, memory and executive functions, and are associated with psychosocial difficulties (adaptive behavior, social interactions). This hidden handicap is the main long-term sequels of CHD, even before cardiovascular sequels, in individuals who often underwent multiple heart operations in early childhood. NDs concern not only complex CHD, but also simple CHD repaired in childhood and considered cured.
The origin of TND associated with CHD is largely unknown. To date, few genetic or environmental causes have been clearly identified, but recent work has suggested that a common origin may link cardiac malformation and neurodevelopmental abnormality.
The CATAMARAN - Pediatrics project is designed to detect potential neurodevelopmental delays associated with CHD as early as age 3, and to identify individual susceptibility factors involved in the occurrence of NDs in CHD children.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CATAMARAN - Pediatrics - Interdisciplinary programme - Nantes Only | Other | Other: Blood sampling, Diagnostic Test: Assessment of neurodevelopment (Nantes), Other: Assessment of the parental stressThe study population will consist of 201 children aged 3 to 11 and their two parents. |
| CATAMARAN - Pediatrics - Unique neuropsychological assessment Associated centers (including Nantes) | Other | Other: Blood sampling, Diagnostic Test: Assessment of neurodevelopment (CA), Other: Assessment of the parental stressThe study population will consist of 201 children aged 3 to 11 and their two parents. |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Child (aged 3 to 11) with critical MCC operated on for heart surgery during the first three months of life
- Parents and child affiliated with or benefiting from a social security or similar scheme
- Parents' and child's good understanding of the French language
- Free, informed and written consent of both parents for themselves and for the child
- Free, informed and written consent of the child aged 6 and over
Key exclusion criteria (2 listed)
- Genetic anomaly or malformative syndrome associated with neurodevelopmental abnormalities, identified prior to inclusion
- Neurodevelopmental assessment not practicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingAn EDTA blood sample will be taken from the children and their two parents. Sample volume will be 2 x 3mL. | Other | CATAMARAN - Pediatrics - Interdisciplinary programme - Nantes Only, CATAMARAN - Pediatrics - Unique neuropsychological assessment Associated centers (including Nantes) |
| Assessment of neurodevelopment (CA)The children will be seen by a neuropsychologist, who will then determine whether or not they have neurodevelopmental disorders. | Diagnostic test | CATAMARAN - Pediatrics - Unique neuropsychological assessment Associated centers (including Nantes) |
| Assessment of neurodevelopment (Nantes)The children will be seen by a multidisciplinary team (including a neuropsychologist), who will then determine whether or not they have neurodevelopmental disorders. | Diagnostic test | CATAMARAN - Pediatrics - Interdisciplinary programme - Nantes Only |
| Assessment of the parental stressParents' parental stress will be assessed using the Parental Stress Index (PSI) questionnaire. | Other | CATAMARAN - Pediatrics - Interdisciplinary programme - Nantes Only, CATAMARAN - Pediatrics - Unique neuropsychological assessment Associated centers (including Nantes) |
Primary outcome
Assessment of the prevalence of neurodevelopmental disorders in children aged 3-11 years with critical congenital heart defects.
Time frame: 14 days
7 secondary outcomes
Identify rare genetic variants associated with genome-wide neurodevelopmental disorders in patients with congenital heart defects.
Time frame: One day
Identify frequent genetic variants associated with genome-wide neurodevelopmental disorders in patients with congenital heart defects.
Time frame: One day
Assessment of the prevalence of neurodevelopmental disorders in children with critical congenital heart defects in each age subgroup (3-5, 6-8, and 9-11 years).
Time frame: up to 14 days
Evaluate and describe the neurodevelopmental domains affected in the pediatric population of Nantes (Multidisciplinary assessment).
Time frame: up to 14 days
Assessment of the quality of life and psychopathological aspects of the child as well as parental stress.
Time frame: up to 14 days
Assessment of diagnostic accuracy (of NDD) provided by an innovative multidisciplinary approach.
Time frame: up to 14 days
Describe the different types of neurodevelopmental disorders (number and nature of neurodevelopmental domains affected) in each age subgroup (intelligence, oral language, motor skills, school learning, executive functions, social interactions).
Time frame: up to 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Congenital Heart Defects
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction
Recruiting
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke
Patent Foramen Ovale, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling, Assessment of neurodevelopment (CA) and Assessment of neurodevelopment (Nantes) in people with Congenital Heart Defects and Neurodevelopmental Disorder, run by Nantes University Hospital at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alban Baruteau (02 40 08 77 42, albanelouen.baruteau@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the prevalence of neurodevelopmental disorders in children aged 3-11 years with critical congenital heart defects. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.