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

Completed

• Conditions: congenital-heart-defect structural-heart-disease; 10010394; 10010335; 10016849

• Registration Number: NL-OMON40959
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

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

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. brain age of healthy control fetuses (a combined parameter of stages of<br /><br>development and cortical folding in the brain);<br /><br>2. brain perfusion of healthy control fetuses;<br /><br>3. brain volume of healthy control fetuses.</p><br>

Secondary Outcome Measures

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