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 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT06175104
Eligibility Criteria:
Inclusion Criteria
1. Pregnant person carrying a fetus diagnosed with single ventricle congenital heart disease (CHD).
2. Single ventricle CHD diagnosis between 16 and 30 weeks gestation.
3. Singleton pregnancy.
4. Pregnant person is planning to continue with the pregnancy.
5. Pregnant person is able to participate and complete study assessments in English.
Exclusion Criteria
1. Fetus with comorbid condition with a predictable adverse impact on neurodevelopment (e.g., DiGeorge Syndrome).
2. Fetal or maternal medical condition determined by treating physician to be contraindicative to study participation.
3. Parent with an untreated major psychiatric condition, substance use disorder, or other circumstances that would interfere with study engagement or safe participation in the trial.
4. Parent with a moderate to severe intellectual disability.
5. Parent age \<18 years.
6. Surrogate for pregnancy.
Prenatal administration of oral or intravenous corticosteroids for fetal lung maturation will be recorded but are not a reason for exclusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06175104
Study Brief:
Protocol Section:
NCT06175104