The Heart And NeuroDevelopment study - Development of the brain in fetuses and children with severe congenital heart disease

The Heart And NeuroDevelopment study - Development of the brain in fetuses and children with severe congenital heart disease - HAND study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40959

Enrollment

Registered

2014-07-08

Start date

2014-09-01

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

congenital-heart-defect structural-heart-disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, women must have a continuing singleton pregnancy of a congenitally normal fetus.

Exclusion criteria

Exclusion criteria: A potential case or control who meets any of the following criteria will be excluded from participation in this study: - Failure to obtain informed consent - Maternal age below 18 years; - Presence of fetal structural anomalies; - High risk for congenital anomalies.

Design outcomes

Primary

Measure	Time frame
1. brain age of healthy control fetuses (a combined parameter of stages of development and cortical folding in the brain); 2. brain perfusion of healthy control fetuses; 3. brain volume of healthy control fetuses.	—

Secondary

Measure	Time frame
1. the development of biometric parameters in healthy control fetuses; 2. the timing of deviation of the aforementioned variables (if they occur, at what gestational age do abnormalities occur during pregnancy); 3. comparison of early postnatal outcome with prenatal characteristics in healthy control fetuses.	—

Countries

Netherlands

Outcome results