Characterizing and Supporting Neurodevelopmental Disorders in Newborns with Critical Congenital Heart Defects Requiring Early Surgery

What this Trial Is About

Congenital heart defects CHD are a major cause of birth defects affecting millions worldwide, including about 41,000 newborns annually in Europe. CHD is linked with high rates of illness and death throughout life, and over half of infants with critical CHD develop neurodevelopmental disorders NDDs. These NDDs involve early disruptions in brain development affecting cognitive, emotional, and behavioral functions, often leading to challenges in language, learning, motor skills, and social interactions. The CATAMARAN neonatal cohort project seeks to detect developmental delays as early as six months in infants with CHD and to identify factors that contribute to these delays. The study includes 150 fetuses diagnosed prenatally with critical CHD requiring cardiac surgery within the first three months of life, along with their two parents. Researchers will perform neurodevelopmental assessments using the Bayley-IV test and collect various biological samples at delivery and during hospitalization for surgery. These samples include maternal and infant blood, placenta tissue, and stool for genetic, metabolomic, microbiome, and other analyses. Additional data on pregnancy, obstetric events, fetal ultrasounds, echocardiography, and parental stress levels will also be gathered. Participants will be monitored at six months of age to evaluate the prevalence and specifics of developmental delays. The study will assess how genetic factors, placental anomalies, maternal behaviors, and surgical details relate to these delays. Parents will complete questionnaires about diet and post-traumatic stress. Researchers will collect cardiovascular and developmental follow-up data, postoperative brain MRI scans, and track neonatal microbiota to better understand the origins and impacts of neurodevelopmental disorders in infants with CHD.

Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac malfoRmations - Neonatal