Heart Disease CongenitalCATAMARAN - NNNCT06690151
Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac malfoRmations - Neonatal
An observational study of Heart Disease Congenital and Neurodevelopmental Disorder, run by Nantes University Hospital at 8 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Disease Congenital, Neurodevelopmental Disorder
- What is being tested?
- Neurodevelopmental assessment (Bayley-IV), Biological sampling and ELFE dietary questionnaire
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 450 participants
- Where
- 8 sitesFrance
- Study dates
- 28 Feb 2025to 28 Aug 2028
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
None listed.
Who cannot join
- Medical termination of pregnancy considered
- Genetic anomaly or malformative syndrome identified prior to inclusion
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
CHU de Bordeaux
Bordeaux
Marion AUDIE, +33 556795679, marion.audie@chu-bordeaux.fr
Marion AUDIE
- Recruiting
APHP - Antoine Béclère
Clamart, 92140
Alexandre VIVANTI, +33 145374366, alexandre.vivanti@aphp.fr
Alexandre VIVANTI
- Recruiting
Hôpital Marie Lannelongue
Le Plessis-Robinson, 92350
Sébastien HASCOËT, +33 140942429, s.hascoet@ghpsj.fr
Sébastien HASCOUËT
- Recruiting
AP-HM
Marseille
Caroline OVAERT, +334 91386496, caroline.ovaert@ap-hm.fr
Caroline OVAERT
- Recruiting
Nantes University Hospital
Nantes, Loire Atlantique, 44093
Alban BARUTEAU, +33 253482835, albanelouen.baruteau@chu-nantes.fr
Alban BARUTEAU
- Not yet recruiting
AP-HP Necker
Paris
Damien BONNET, +33 144494344, Damien.bonnet@aphp.fr
Damien BONNET
- Not yet recruiting
CHU de Toulouse
Toulouse, 31000
Khaled HADEED, +33 5 34 55 74 73, Hadeed.k@chu-toulouse.fr
Paul GUERBY, +33 567771106, guerby.p@chu-toulouse.fr
- Recruiting
CHRU Tours
Tours
Bruno LEFORT, +33 247474755, b.lefort@univ-tours.fr
Franck PERROTIN
About this study
Official title: CATAMARAN - Neonatal Cohort : Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac malfoRmations - Neonatal
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.
- Being tested
- Neurodevelopmental assessment (Bayley-IV), Biological sampling, ELFE dietary questionnaire, Post-Traumatic Stress Questionnaire IES-R (Impact of Event Scale - Revised), Data collection for the study (Cardiovascular, developemental, fetal, pregnancy, MRI)
- Keywords
- Congenital heart defects (CHD), neurodevelopmental disorders (NDD), 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.
Neurodevelopmental assessment (Bayley-IV)Behavioural
Assessment of developmental delays through administration of the Bayley-4 test by a neuropsychologist
Biological samplingOther
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 questionnaireBehavioural
Questionnaire on diet and lifestyle during pregnancy (only for the mother)
Post-Traumatic Stress Questionnaire IES-R (Impact of Event Scale - Revised)Behavioural
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)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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the prevalence of developmental delays in infants with a critical congenital heart defect (CHD) at 6 months of age.
Measured: 6 months
Secondary outcomes (14)
Evaluate the prevalence of developmental delay in infants with congenital heart defects (CHD) based on the type of heart defect.
Measured: 6 months
Assess the presence of developmental delay in infants with CHD based on the complexity of cardiac surgery.
Measured: 6 months
Evaluate and describe affected developmental domains.
Measured: 6 months
Identify rare genetic variants associated with developmental delays in CHD patients through genome-wide analysis.
Measured: 6 months
Identify common genetic variants associated with developmental delays in CHD patients through genome-wide analysis.
Measured: 6 months
Characterize placental anatomopathological anomalies in CHD and their correlation with developmental delay at 6 months.
Measured: 6 months
Determine maternal dietary habits during the third trimester, their correlation with placental anomalies, and developmental delay at 6 months.
Measured: 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
Measured: 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
Measured: 6 months
Characterize neonatal microbiota and its association with developmental delay at 6 months.
Measured: 6 months
Identify perioperative determinants of developmental delay in CHD.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start28 Feb 2025
- Primary completion28 Aug 2028 (estimated)
- Study completion28 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Disease CongenitalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pays de la Loire Laboratory of Psychology (LPPL), Physiopathology of Nutritional Adaptations Joint Research Unit (UMR PhAN), Institut du thorax, INSERM UMR1087
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690151
- Sponsor's protocol ID
- RC23_0547
- Other IDs
- IDRCB (ANSm) : 2024-A00425-42
- Acronym
- CATAMARAN - NN
- Status last verified
- Jun 2026
- First submitted
- 13 Nov 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Werner O, Ferchaud-Roucher V, Karakachoff M, Bourgoin P, Chauvire-Drouard A, Galy J, Cosse M, Chaffiraud M, Boivin M, Gauvard E, Egron S, Romefort B, Benbrik N, Padovani P, Prigent S, Tagorti M, Demonceaux M, Gronier CG, Laribi J, Monier A, Winer N, Gaillard Le Roux B, Flamant C, Amarger V, Moyon T, Blottiere H, Forest V, Lindenbaum P, Dina C, Redon R, Barc J, Ebstein F, Schott JJ, Guerra A, Cadeau O, Roy A, Baruteau AE; CATAMARAN Study Group. Clinical and multi-omics characterisation of early neurodevelopmental disorders associated with critical congenital heart disease: the prospective cohort CATAMARAN neonatal study protocol. BMJ Open. 2026 Sep 8;16(9):e116866. doi: 10.1136/bmjopen-2026-116866.
PubMed 42711078
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CATAMARAN - Neonatal Cohort : Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac malfoRmations - Neonatal
- ClinicalTrials.gov ID
- NCT06690151
- Acronym / sponsor ID
- CATAMARAN - NN / RC23_0547
- Keywords
- Congenital heart defects (CHD), neurodevelopmental disorders (NDD), genetics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Pays de la Loire Laboratory of Psychology (LPPL), Physiopathology of Nutritional Adaptations Joint Research Unit (UMR PhAN), Institut du thorax, INSERM UMR1087
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 28 Aug 2028 (estimated)
- Study completion
- 28 Aug 2028 (estimated)
- First posted
- 15 Nov 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population (Newborns with congenital heart defects 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)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Medical termination of pregnancy considered
- Genetic anomaly or malformative syndrome identified prior to inclusion
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 |
|---|---|---|
| Neurodevelopmental assessment (Bayley-IV)Assessment of developmental delays through administration of the Bayley-4 test by a neuropsychologist | Behavioural | Study population (Newborns with congenital heart defects and their two parents) |
| Biological samplingThe 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. | Other | Study population (Newborns with congenital heart defects and their two parents) |
| ELFE dietary questionnaireQuestionnaire on diet and lifestyle during pregnancy (only for the mother) | Behavioural | Study population (Newborns with congenital heart defects and their two parents) |
| 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. | Behavioural | Study population (Newborns with congenital heart defects and their two parents) |
| 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). | Other | Study population (Newborns with congenital heart defects and their two parents) |
Primary outcome
Evaluate the prevalence of developmental delays in infants with a critical congenital heart defect (CHD) at 6 months of age.
Time frame: 6 months
14 secondary outcomes
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
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 1 Jul 2026.
- Derived from this study: PubMed 42711078Werner O, Ferchaud-Roucher V, Karakachoff M, Bourgoin P, Chauvire-Drouard A, Galy J, Cosse M, Chaffiraud M, Boivin M, Gauvard E, Egron S, Romefort B, Benbrik N, Padovani P, Prigent S, Tagorti M, Demonceaux M, Gronier CG, Laribi J, Monier A, Winer N, Gaillard Le Roux B, Flamant C, Amarger V, Moyon T, Blottiere H, Forest V, Lindenbaum P, Dina C, Redon R, Barc J, Ebstein F, Schott JJ, Guerra A, Cadeau O, Roy A, Baruteau AE; CATAMARAN Study Group. Clinical and multi-omics characterisation of early neurodevelopmental disorders associated with critical congenital heart disease: the prospective cohort CATAMARAN neonatal study protocol. BMJ Open. 2026 Sep 8;16(9):e116866. doi: 10.1136/bmjopen-2026-116866.
- Individual participant dataSharing planned: Undecided
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Disease Congenital and Neurodevelopmental Disorder, run by Nantes University Hospital at 8 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 0 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 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 (+33 2 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?
Evaluate the prevalence of developmental delays in infants with a critical congenital heart defect (CHD) at 6 months of age. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06690151, which also lists 1 linked publication.
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 1 Jul 2026.