Actively Recruiting
CATAMARAN - Neonatal Cohort: Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac Malformations
Led by Nantes University Hospital · Updated on 2026-03-20
450
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
Sponsors
N
Nantes University Hospital
Lead Sponsor
P
Pays de la Loire Laboratory of Psychology (LPPL)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Congenital heart defects (CHD) affect millions worldwide and are a leading cause of birth defects, with many newborns in Europe affected each year. CHD is linked to a high risk of neurodevelopmental disorders (NDD), which can impact many areas such as language, learning, motor skills, and social behavior. This research aims to detect developmental delays as early as six months in infants with critical CHD and to understand factors that contribute to these delays, including genetic, environmental, and clinical influences. The study will involve 150 fetuses diagnosed prenatally with critical CHD that requires surgery within the first three months of life, along with their parents. Researchers will conduct detailed neurodevelopmental assessments, including the Bayley-IV test, and collect biological samples from the mother, father, infant, placenta, and meconium. Additional data will be gathered through questionnaires about maternal diet and stress, as well as information on cardiac surgeries and postoperative brain imaging. These activities aim to explore how various factors relate to developmental outcomes. Participants will be monitored from prenatal diagnosis through the infant's surgery and up to six months of age. The study includes collecting cardiovascular and developmental follow-up data, fetal ultrasounds, and brain MRI scans after surgery. Researchers will evaluate developmental delays at six months and analyze genetic, environmental, and perioperative factors that may influence neurodevelopment. Parental stress levels will also be assessed to understand their relationship to infant development. The total study duration spans from prenatal inclusion through six months post-surgery.
CONDITIONS
Brief Title
Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac malfoRmations - Neonatal
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fetus with a congenital heart defect diagnosed before birth
- Fetus with a critical congenital heart defect requiring surgery within the first three months of life
- Both parents affiliated with a social security or equivalent system
- Both parents have good understanding of the French language
- Voluntary, informed, and written consent from both parents for themselves and the unborn child
- Participants include biological parents, with father encouraged but not required to participate
You will not qualify if you...
- Medical termination of pregnancy planned or considered
- Genetic anomaly or malformative syndrome identified before inclusion
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From prenatal period until delivery
Participants undergo various assessments including cardiovascular, developmental, fetal ultrasound, fetal echocardiography, and obstetric data collection.
Multiple visits during pregnancy including T2 and T3 fetal ultrasounds and echocardiographies
Duration - At delivery and during hospitalization for cardiac surgery
Participants provide biological samples such as maternal blood, cord blood, placenta samples, meconium sample at birth, and genome and neurobiomarker samples during hospitalization for cardiac surgery.
Samples collected once at delivery and multiple times during hospitalization for surgery
Duration - Until 6 months of age
Participants undergo neurodevelopmental assessment using the Bayley-IV test conducted by a neuropsychologist.
Assessments occurring up to 6 months after birth
Duration - Up to 6 months post-surgery
Parents complete the Post-Traumatic Stress Questionnaire (IES-R) at antenatal inclusion, perioperative period, and 6 months post-surgery.
3 questionnaire assessments at specified time points
Duration - Up to 6 months after birth
Participants are monitored for developmental delays, microbiota characterization, and postoperative brain MRI data collection during hospitalization and up to 6 months of age.
MRI performed between Day 5 post-surgery and hospital discharge; stool sample at 1 month; follow-up assessments up to 6 months
Trial Site Locations
Total: 8 locations
1
Nantes University Hospital
Nantes, Loire Atlantique, France, 44093
Actively Recruiting
2
CHU de Bordeaux
Bordeaux, France
Actively Recruiting
3
APHP - Antoine Béclère
Clamart, France, 92140
Actively Recruiting
4
Hôpital Marie Lannelongue
Le Plessis-Robinson, France, 92350
Actively Recruiting
5
AP-HM
Marseille, France
Actively Recruiting
6
AP-HP Necker
Paris, France
Not Yet Recruiting
7
CHU de Toulouse
Toulouse, France, 31000
Not Yet Recruiting
8
CHRU Tours
Tours, France
Actively Recruiting
Research Team
A
Alban Baruteau
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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