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RECRUITING
NCT06711666

Prenatal Maternal Mental Health and Neurodevelopment in Congenital Heart Disease

Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

View on ClinicalTrials.gov

Summary

Congenital heart disease (CHD) is the leading cause of congenital malformations, representing 1% of live births. Progress in surgical care have led to the dramatic increase in the population of children and adults living with heart disease. As survival is no longer a concern, long-term outcomes have become the major public health issue. Prenatal diagnosis of CHD requiring open-heart surgery can be a traumatic event for expecting mothers and fathers. In the general population, maternal mental health distress is associated with fetal disturbances in the hypothalamic-adrenal-pituitary system axis, restricted intrauterine growth and adverse outcomes in the offspring. It is unknown whether prenatal maternal psychological distress have an impact on neurodevelopmental outcomes in CHD. Our national study seeks to (1) characterize the impact of prenatal maternal psychological distress on neurodevelopmental outcomes at age 1 for children with CHD who undergo neonatal open-heart surgery; (2) investigate the sociodemographic and medical determinants associated with prenatal maternal mental health of women carrying a foetus diagnosed with complex CHD; (3) explore the mediating role of prenatal risk factors (i.e., sociodemographic, medical and maternal coping mechanisms) in the association of prenatal maternal mental health (i.e., distress, anxiety and depression) and neurodevelopment in children with CHD; and (4) explore the impact of paternal or the co-parent's mental health impact on neurodevelopmental outcomes at age 1 in children with CHD. This study is a non-interventional, prospective, and longitudinal study of prenatal maternal mental health and subsequent child's neurodevelopmental and behavioural outcomes. It includes a follow-up period from the 3rd trimester of pregnancy until the child's first year of life. It will include children with a prenatally diagnosed heart defect requiring open-heart surgery within the first weeks of life. Understanding and preventing the neurodevelopmental sequelae of heart disease diagnosed in-utero is a public health priority.

Official title: Prenatal Maternal Mental Health and Neurodevelopment in Children With an Antenatal Diagnosis of Congenital Heart Disease: The Neuro-Moms CHD Study

Key Details

Gender

All

Age Range

Any - 50 Years

Study Type

OBSERVATIONAL

Enrollment

87

Start Date

2025-06-27

Completion Date

2028-01

Last Updated

2026-02-12

Healthy Volunteers

No

Locations (5)

Hopital de Marseille la Timone

Marseille, France

CHU de Montpellier

Montpellier, France

Institut Saint Pierre

Palavas-les-Flots, France

Hopital Necker Enfants Malades

Paris, France

Hopital Haut Leveque

Pessac, France