Neuro-Moms
Sponsor study identifier
Secondary identifiers
REGISTRY · IDRCB
observational
174
1 country
5
Study Start
June 27, 2025
Actual (reported)Primary Completion
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 20, 2024
Actual (reported)December 2, 2024
Actual (reported)June 27, 2025
Actual (reported)October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Global Mental Health Self-questionnaire, The Symptom Checklist-90-Revised SCL-90 R (min score 20 - max score 80)
Mental Health Self-Report, Higher scores indicate worse outcomes
Time 1 Prenatal Visit and Time 3 1-year old Visit
Bayley Scales of Infant and Toddler Development (BAYLEY-4) (min score 50- max score 150)
Standardized Neurodevelopmental Assessment, Higher scores better outcome, Mean 100; SD 15
Time 3 1-year old Visit
State-Trait Anxiety Inventory (STAI-Y) (min score 20 - max score 80)
Time 1 Prenatal Visit, Time 2 immediately after the neonatal open-heart surgery during postoperative hospitalization, Postoperative Visit and Time 3 1-year old Visit
Expecting women diagnosed with a foetal complex congenital heart disease. Fathers or co-parent of prenatally diagnosed children with CHD Children with complex congenital heart disease who require neonatal open-heart surgery.
Hopital de Marseille la Timone
Marseille, France
CHU de Montpellier
Montpellier, France
Institut Saint Pierre
Deninotti J, Derridj N, Martins S, Laux D, Stos B, Levy M, Desnous B, Guillaumont S, Amedro P, Chabaneix J, Pfister M, Marguin G, Desmure G, Vincenti M, Bonnet D, Calderon J. Prenatal maternal mental health and neurodevelopment in congenital heart disease in France: the neuro-moms CHD multicentre prospective study protocol. BMJ Open. 2025 Dec 23;15(12):e104889. doi: 10.1136/bmjopen-2025-104889.
First Submitted
November 20, 2024
First Posted
December 2, 2024
Study Start
June 27, 2025
Actual (reported)Primary Completion
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Coping Inventory for Stressful Situations (CISS), (min score 20 - max score 80)
Time 1 Prenatal Visit and Time 3 1-year old Visit
Post-partum depression Edinburgh Scale (EPDS) (min score 0 - max score 30)
Time 2 immediately after the neonatal open-heart surgery during postoperative hospitalization, Postoperative Visit
Post-Traumatic Stress Scale (PCL-5), (min score 0 - max score 80)
Time 3 1-year old Visit
Ages and Stages Parent Report, 3rd Edition (min score 0 - max score 60)
Time 3 1-year old Visit
Contact the study team to confirm eligibility.
Palavas-les-Flots, France
Hopital Necker Enfants Malades
Paris, France
Hopital Haut Leveque
Pessac, France
Study Completion
February 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 30, 2026
Record last verified: 2026-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: