Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2025-12-24 @ 4:26 PM
NCT ID:
NCT06711666
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.
Exclusion 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.
Exclusion 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 children with CHD:
1\. Genetic anomalies, brain malformations that may render difficult the neurodevelopmental assessment.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
50 Years
Study:
NCT06711666
Study Brief:
Protocol Section:
NCT06711666