RecruitingPhase 2/3

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

United States150 participantsStarted 2021-12-17

Plain-language 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.

Who can participate

Age range0 Years – 52 Years

SexFEMALE

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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

What they're measuring

Pre-operative Neonatal Network Neurobehavioral Scale (NNNS) attention scores

Timeframe: <=30 days of life

Baseline MCA-PI and change in MCA-PI with Maternal Hyperoxia

Timeframe: <= 30 days of life

Trial details

NCT IDNCT05767385

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

Contact for this trial

Whitnee Hogan, MD

801-213-3599 whitnee.hogan@hsc.utah.edu

View on ClinicalTrials.gov More Congenital Heart Disease in Children trials