Fetal Cerebrovascular Autoregulation in Congenital Heart Disease and Association With Neonatal Neurobehavior

Completed · Phase 2/Phase 3

Conditions studied: Congenital Heart Disease in Children, Hypoxia, Neurodevelopmental Disorders, Complex Congenital Heart Disease

In brief

Determine 1) the impact of abnormal fetal cerebrovascular physiology with neurodevelopmental delay (ND) outcomes and 2) how this relationship is modified by patient and environmental factors such as chronic congenital heart disease (CCHD) lesion, maternal-fetal environment, and social determinants of heath (SDOH) in a diverse population using a multicenter design. Pregnant women will be approached during one of their fetal cardiology clinic visits.

Key facts

Study ID

NCT05767385

Run by

University of Utah

People needed

104

Starts

2021-12-17

Expected to finish

2025-12-31

Last updated by the study team

2026-07-14

Who can join

Age: any, up to 52. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Pregnant women 18 years of age and over with a singleton fetus with known or suspected congenital heart disease anticipated to need intervention or surgery within 30 days of birth.

You may not qualify if…

• Known fetal chromosomal or genetic abnormalities
• Multiple gestation pregnancy
• Fetal extra-cardiac anomalies

Where it is running

• University of California San Francisco — San Francisco, California, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Maine Medical Center — Scarborough, Maine, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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