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RecruitingPhase 2, Phase 3NCT05767385

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

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Trial Parameters

ConditionCongenital Heart Disease in Children
SponsorUniversity of Utah
Study TypeINTERVENTIONAL
PhasePhase 2, Phase 3
Enrollment150
SexFEMALE
Min Age0 Years
Max Age52 Years
Start Date2021-12-17
Completion2025-12
Interventions
Single ArmNeonatal Neurobehavioral Scale

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Brief 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 Criteria

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

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