Clinical and multi-omics characterisation of early neurodevelopmental disorders associated with critical congenital heart disease: the prospective cohort CATAMARAN neonatal study protocol
Abstract
INTRODUCTION: Critical congenital heart disease (CHD) is associated with neurodevelopmental disorders, recognised as the most common long-term morbidity in affected children. In critical CHD, that is, CHD requiring cardiac surgery within the first 3 months of life, 30%-50% of children have lower developmental scores. Therefore, early identification of at-risk infants is crucial, yet there is no scientifically evaluated care programme in France. This study aims to evaluate early neurodevelopmental status in infants with prenatally diagnosed critical CHD and to determine how intrinsic susceptibility, prenatal and postnatal factors are functionally associated with developmental delay in this population. METHODS AND ANALYSIS: Caractérisation et Accompagnement des Troubles du neurodéveloppement Associés aux MAlfoRmations cArdiaques coNgénitales (CATAMARAN) is a prospective, multicentre cohort study including 150 fetuses with critical CHD and their parents across eight French tertiary CHD centres. The primary objective will be to estimate the proportion of developmental delay at 6 months using the Bayley Scales of Infant and Toddler Development. Secondary objectives will include exploring potential prenatal, perinatal, perioperative determinants of developmental delay. Data collection will span pregnancy to 6 months of age including clinical assessments, maternal questionnaires (stress and nutrition), multimodal imaging and extensive biobanking (placenta, cord and peripheral blood, stool samples). To explore potential genetic and other multi-omic factors involved in the occurrence of a developmental delay, a case-control analysis will be conducted within the cohort. ETHICS AND DISSEMINATION: Clinical and biological data will be collected through a secure system, with anonymised samples analysed in specialised facilities under collaborative agreements. Data confidentiality, traceability and long-term storage are ensured through controlled access and audit trails. Study results will be published and shared with families and the public through the patient association Petit Coeur de Beurre. This study received approval from a French ethics committee in November 2024 (no. 2024-A00425-42). TRIAL REGISTRATION NUMBER: NCT06690151.
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BibTeX
@article{werner2026clinical,
title = {{Clinical and multi-omics characterisation of early neurodevelopmental disorders associated with critical congenital heart disease: the prospective cohort CATAMARAN neonatal study protocol}},
author = {Oscar Werner and Véronique Ferchaud-Roucher and Matilde Karakachoff and Pierre Bourgoin and Anne Chauvire-Drouard and Jules Galy and Mathilde Cosse and Mélissa Chaffiraud and Marion Boivin and Evelyne Gauvard and Solène Egron and Bénédicte Romefort and Nadir Benbrik and Paul Padovani and Solene Prigent and Maha Tagorti and Marie Demonceaux and Céline Grunenwald Gronier and Jihed Laribi and Astrid Monier and Norbert Winer and Bénédict Gaillard Le Roux and Cyril Flamant and Valérie Amarger and Thomas Moyon and Hervé Blottière and Virginie Forest and Pierre Lindenbaum and Christian Dina and Richard Redon and Julien Barc and Frédéric Ebstein and Jean-Jacques Schott and Amanda Guerra and Olivier Cadeau and Arnaud Roy and Alban-Elouen Baruteau},
journal = {BMJ Open},
year = {2026},
month = sep,
doi = {10.1136/bmjopen-2026-116866},
url = {https://hal.science/hal-05749799v1},
note = {CC BY},
}
RIS
TY - JOUR
TI - Clinical and multi-omics characterisation of early neurodevelopmental disorders associated with critical congenital heart disease: the prospective cohort CATAMARAN neonatal study protocol
AU - Oscar Werner
AU - Véronique Ferchaud-Roucher
AU - Matilde Karakachoff
AU - Pierre Bourgoin
AU - Anne Chauvire-Drouard
AU - Jules Galy
AU - Mathilde Cosse
AU - Mélissa Chaffiraud
AU - Marion Boivin
AU - Evelyne Gauvard
AU - Solène Egron
AU - Bénédicte Romefort
AU - Nadir Benbrik
AU - Paul Padovani
AU - Solene Prigent
AU - Maha Tagorti
AU - Marie Demonceaux
AU - Céline Grunenwald Gronier
AU - Jihed Laribi
AU - Astrid Monier
AU - Norbert Winer
AU - Bénédict Gaillard Le Roux
AU - Cyril Flamant
AU - Valérie Amarger
AU - Thomas Moyon
AU - Hervé Blottière
AU - Virginie Forest
AU - Pierre Lindenbaum
AU - Christian Dina
AU - Richard Redon
AU - Julien Barc
AU - Frédéric Ebstein
AU - Jean-Jacques Schott
AU - Amanda Guerra
AU - Olivier Cadeau
AU - Arnaud Roy
AU - Alban-Elouen Baruteau
PY - 2026
DA - 2026/09/08
JO - BMJ Open
DO - 10.1136/bmjopen-2026-116866
UR - https://hal.science/hal-05749799v1
AB - INTRODUCTION: Critical congenital heart disease (CHD) is associated with neurodevelopmental disorders, recognised as the most common long-term morbidity in affected children. In critical CHD, that is, CHD requiring cardiac surgery within the first 3 months of life, 30%-50% of children have lower developmental scores. Therefore, early identification of at-risk infants is crucial, yet there is no scientifically evaluated care programme in France. This study aims to evaluate early neurodevelopmental status in infants with prenatally diagnosed critical CHD and to determine how intrinsic susceptibility, prenatal and postnatal factors are functionally associated with developmental delay in this population. METHODS AND ANALYSIS: Caractérisation et Accompagnement des Troubles du neurodéveloppement Associés aux MAlfoRmations cArdiaques coNgénitales (CATAMARAN) is a prospective, multicentre cohort study including 150 fetuses with critical CHD and their parents across eight French tertiary CHD centres. The primary objective will be to estimate the proportion of developmental delay at 6 months using the Bayley Scales of Infant and Toddler Development. Secondary objectives will include exploring potential prenatal, perinatal, perioperative determinants of developmental delay. Data collection will span pregnancy to 6 months of age including clinical assessments, maternal questionnaires (stress and nutrition), multimodal imaging and extensive biobanking (placenta, cord and peripheral blood, stool samples). To explore potential genetic and other multi-omic factors involved in the occurrence of a developmental delay, a case-control analysis will be conducted within the cohort. ETHICS AND DISSEMINATION: Clinical and biological data will be collected through a secure system, with anonymised samples analysed in specialised facilities under collaborative agreements. Data confidentiality, traceability and long-term storage are ensured through controlled access and audit trails. Study results will be published and shared with families and the public through the patient association Petit Coeur de Beurre. This study received approval from a French ethics committee in November 2024 (no. 2024-A00425-42). TRIAL REGISTRATION NUMBER: NCT06690151.
SN - 2044-6055
ER -