Prenatal Maternal Mental Health and Neurodevelopment in Congenital Heart Disease

Not yet recruiting

• Conditions: Congenital Heart Disease; Cyanotic Congenital Heart Disease; d-Transposition of the Great Arteries; Hypoplastic Left Heart Syndrome

• Registration Number: NCT06711666
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

Brief 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.

Detailed Description

This study is a non-interventional, prospective, and longitudinal study of prenatal maternal mental health and subsequent child's neurodevelopmental and behavioural outcomes in congenital heart disease. It includes a follow-up period from the 3rd trimester of pregnancy until the child's first year of life (between 12 and 18 months). It will include children with a prenatally diagnosed critical heart defect (i.e., cyanotic types of CHD with the potential to cause rapid hypoxemia after birth) requiring neonatal open-heart surgery (within the first weeks of life).

Expecting mothers who agree to participate will undergo comprehensive psychological evaluations conducted by a licensed mental health professional with defined expertise in perinatal mental health. Fathers or co-parent of the child with foetal CHD will also participate in self-reports during the prenatal period. A total of three time points of psychological assessment will be done: Time 1, during the prenatal period, after 28 weeks of gestation); Time 2, an interim self-report assessment using only questionnaires before post-surgery hospital discharge for the baby (after intensive care transfer to hospitalization); and Time 3, 1 year after the birth of their child. Maternal assessments will include standardized self-report measures of stress, anxiety, depression and other psychological symptoms as well as a clinical interview for Time 1 and 2. Co-parent assessment at Time 1 will include self-reports of overall mental health, anxiety and coping skills.

Infant neurodevelopmental and behavioural assessments will be conducted at year 1 (between 12-18 months for the child) during a joint visit of the dyad mother-child. All assessments will be standardized and have French norms and instructions for parents and the child. These assessments will evaluate areas such as cognition, emerging language, and motor skills (gross and fine motor abilities). Socio-behavioural outcomes will also be evaluated at this time. All infant developmental assessments will be administered by paediatric neuropsychologists.

Study Timeline

• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-28
• Study First Posted: 2024-12-02
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15
• Study Start: 2025-05
• Primary Completion: 2027-09
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Ages and Stages Parent Report, 3rd Edition (min score 0 - max score 60)	Time 3 1-year old Visit	Developmental questionnaire for parents, Higher scores worse outcomes
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	Anxiety self-report, Higher scores worse outcomes
Coping Inventory for Stressful Situations (CISS), (min score 20 - max score 80)	Time 1 Prenatal Visit and Time 3 1-year old Visit	Coping self-report, Higher scores better outcomes
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-partum depression self-report, Higher scores worse outcomes
Post-Traumatic Stress Scale (PCL-5), (min score 0 - max score 80)	Time 3 1-year old Visit	Self-report scale on PTSD symptoms, Higher scores worse outcomes