Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in France / NCT06711666
Recruiting Observational

Prenatal Maternal Mental Health and Neurodevelopment in Congenital Heart Disease

NCT06711666 · tracked via the Priya Life Science France tracker
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Phase
Observational
Started
2025-06-27
Last updated
2026-07-30

Condition(s) studied

Congenital Heart DiseaseCyanotic Congenital Heart Diseased-Transposition of the Great ArteriesHypoplastic Left Heart Syndrome

Study 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.

Eligibility

Sex
ALL
Min age
—
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria for the mother of a child diagnosed with CHD: 1. Age at least 18 years old 2. Expecting women 3. Having received a diagnosis of foetal critical cyanotic CHD (i.e., CHD physiology that can compromise blood oxygenation after birth). This type of CHDs corresponds to the highest level of neurological risk as reported by the American Heart Association guidelines(1). 4. Pregnancy of at least 28 weeks of gestation (third trimester) and up to the 38 weeks of gestation at the time of enrolment and prenatal visit for the study. 5. Medical maternal and paediatric cardiology follow-up in one of the investigating hospitals (Montpellier, Necker Children's Hospital in Paris and Bordeaux). 6. A delay of a minimum of 4 weeks between the initial diagnosis of foetal congenital heart disease. 7. Social security affiliation in France. Inclusion criteria for the father or co-parent: 1. Co-parent of an expecting woman participating in the study 2. Age at least 18 years old 3. Social security affiliation in France. Inclusion criteria for the child diagnosed with congenital heart disease: 1. Child with a prenatal diagnosis of isolated complex congenital heart disease, born to a mother already participating in the study 2. Written consent from both parents 3. Social security affiliation in France. Non-inclusion Criteria for mothers: 1. Patient refusal to participate 2. Participants (i.e., expecting women) who express a wish for medical termination of pregnancy 3. Diagnosis of a complex CHD associated with another foetal comorbidity with a clinically recognized impact on neurodevelopment (e.g., genetic syndromes such as trisomies, poly-malformation syndromes). 4. Participants who are not able to understand the instructions and/or complete the self-reports 5. Expecting women who currently have a major psychiatric condition (e.g., untreated major depression, severe anxiety disorders, psychotic disorders) with or without treatment, at the time of the cardiology consultation or at the time of the first psychological evaluation. Patients who will be excluded due to these conditions will be referred for perinatal psychiatric consultation. 6. Persons under legal or judicial guardianship. Non-inclusion Criteria for fathers or co-parents: 1. Patient refusal to participate 2. Participants with a severe psychiatric disorder (severe depression, psychotic disorders) with or without treatment 3. Persons under legal or judicial guardianship. Exclusion Criteria for the mother of a child diagnosed with CHD: 1\. The child has not undergone surgery within 60 days of birth. Exclusion Criteria for children with CHD: 1\. Genetic anomalies, brain malformations that may render difficult the neurodevelopmental assessment.

Primary outcome measure(s)

  • Global Mental Health Self-questionnaire, The Symptom Checklist-90-Revised SCL-90 R (min score 20 - max score 80) — Time 1 Prenatal Visit and Time 3 1-year old Visit
    Mental Health Self-Report, Higher scores indicate worse outcomes
  • Bayley Scales of Infant and Toddler Development (BAYLEY-4) (min score 50- max score 150) — Time 3 1-year old Visit
    Standardized Neurodevelopmental Assessment, Higher scores better outcome, Mean 100; SD 15

Trial sites (5)

FacilityCityRegionStatus
Hopital de Marseille la Timone Marseille France Recruiting
CHU de Montpellier Montpellier France Recruiting
Institut Saint Pierre Palavas-les-Flots France Recruiting
Hopital Necker Enfants Malades Paris France Recruiting
Hopital Haut Leveque Pessac France Recruiting

More Institut National de la Santé Et de la Recherche Médicale, France trials in France

French Childhood Cancer Survivor Study Recruiting
Neural Correlates of Movement Disorders Associated With PRRT2 Related Paroxysmal Kinesigenic Dyskinesia - an Ancillary Study of AMEDYST Research Recruiting
Validation and Implementation of 3T MRI Research Protocols Recruiting
Mechanism of Action of Interferon in the Treatment of Myeloproliferative Neoplasms Recruiting
Bronchial Epithelium of Children With Post-infectious Bronchiolitis Obliterans Recruiting

Other trials for the same condition

Antenatal Investigation of Fetuses With Complex Congenital Heart Defects Using multiOMICS Recruiting
Neuro-cardiac Rehabilitation in Youth With Congenital Heart Disease (QUALINEUROREHAB) Recruiting
International Multicenter Outcomes of Transcatheter Pulmonary Flow Restrictors in Congenital and Acquired Heart Disease Enrolling by invitation
French National Registry of Patients With Tetralogy of Fallot and Implantable Cardioverter Defibrillator Recruiting
OPTImal Treatment of Sinus VENOSUS Defect Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06711666 on ClinicalTrials.gov ↗ ← All trials in France