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

RECRUITINGPhase 2/3Sponsored by University of Utah
Actively Recruiting
PhasePhase 2/3
SponsorUniversity of Utah
Started2021-12-17
Est. completion2025-12
Eligibility
Age0 Years – 52 Years
SexFEMALE
Healthy vol.Accepted
Locations5 sites
View on ClinicalTrials.gov →

NCT05767385

Summary

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.

Eligibility

Age: 0 Years – 52 YearsSex: FEMALEHealthy volunteers accepted
Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Conditions5

Complex Congenital Heart DiseaseCongenital Heart Disease in ChildrenHeart DiseaseHypoxiaNeurodevelopmental Disorders

Locations5 sites

California

1 site
University of California San Francisco
San Francisco, California, 94143
Disha Goeldisha.goel@ucsf.edu

District of Columbia

1 site
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Jennifer Klein, MDJKlein@childrensnational.org

Maine

1 site
Maine Medical Center
Scarborough, Maine, 04074
Thomas Miller, DO207-883-5532Thomas.A.Miller@mainehealth.org

Utah

2 sites
Primary Children's Hospital
Salt Lake City, Utah, 84113
University of Utah
Salt Lake City, Utah, 84132
Lisa M Hansen, BA801-587-9104lisa.hansen@hsc.utah.edu

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