Prenatal maternal mental health and infant brain development in congenital heart defects

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

See if prenatal maternal psychological distress is linked to neurodevelopment at age one in babies with prenatally diagnosed critical cyanotic congenital heart defects who need neonatal open-heart surgery.

Quick facts

• Study type: Observational
• Enrollment: 174 (estimated)
• Ages: N/A to 50 Years
• Sex: All
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France (Government)
• Locations: 5 sites (Marseille and 4 other locations)
• Trial ID: NCT06711666 on ClinicalTrials.gov

What this trial studies

This is a prospective, longitudinal observational study enrolling expecting mothers after 28 weeks gestation who have received a prenatal diagnosis of a critical cyanotic congenital heart defect requiring neonatal open-heart surgery. Participants undergo comprehensive maternal psychological evaluations by perinatal mental health professionals and standardized self-report measures, with co-parents completing questionnaires at baseline. Assessments occur at three time points: late pregnancy, before neonatal hospital discharge after surgery, and at the child's first birthday (12–18 months). The study follows children from the third trimester through their first year to relate prenatal parental mental health to early neurodevelopmental and behavioral outcomes.

Who should consider this trial

Good fit: Expecting women aged 18+ between 28 and 38 weeks gestation with a prenatal diagnosis of a critical cyanotic CHD requiring neonatal open-heart surgery, receiving follow-up at one of the participating French hospitals and covered by French social security (co-parents aged 18+ may also participate).

Not a fit: Pregnant people whose fetus does not have a prenatal diagnosis of critical cyanotic CHD, whose infants will not require neonatal open-heart surgery, or who cannot attend participating hospitals in France are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the findings could identify parental mental health factors that, when addressed, may improve early neurodevelopmental outcomes for infants with critical CHD.

How similar studies have performed: Prior research in the general population links prenatal maternal distress to adverse child neurodevelopment, but effects specifically in infants with critical CHD are largely untested, making this approach relatively novel for this group.

Eligibility criteria

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.

Where this trial is running

Marseille and 4 other locations

• 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)

Study contacts

• Study coordinator: Johanna Calderon, PhD

Conditions Congenital Heart Disease; Cyanotic Congenital Heart Disease; d-Transposition of the Great Arteries; Hypoplastic Left Heart Syndrome; psychological stress; Maternal prenatal mental health; Neurodevelopment; Cyanotic congenital heart disease