Fetal Cerebrovascular Autoregulation in Congenital Heart Disease and Association With Neonatal Neurobehavior
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: Female
Maximum Age: 52
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
University of California San Francisco
NOT_YET_RECRUITING
San Francisco
Washington, D.c.
Children's National Medical Center
NOT_YET_RECRUITING
Washington D.c.
Maine
Maine Medical Center
NOT_YET_RECRUITING
Scarborough
Utah
Primary Children's Hospital
NOT_YET_RECRUITING
Salt Lake City
University of Utah
RECRUITING
Salt Lake City
Contact Information
Primary
Whitnee Hogan, MD
whitnee.hogan@hsc.utah.edu
801-213-3599
Backup
Lisa M. Hansen, BA
lisa.hansen@hsc.utah.edu
801-587-9104
Time Frame
Start Date: 2021-12-17
Estimated Completion Date: 2025-12
Participants
Target number of participants: 150
Treatments
Experimental: Single Arm
Maternal Hyperoxia (MH) will be administered to pregnant patients after their standard of care fetal echocardiogram has been performed at their scheduled fetal cardiology visit at ³28 weeks gestation. The evaluation at ³28 weeks was chosen since gestational age impacts both the cardiovascular and cerebrovascular response to MH.31 The evaluation will extend the duration of the visit by approximately 30 minutes but additional evaluations or visits for the study will not be required.
Related Therapeutic Areas
Sponsors
Leads: University of Utah
Collaborators: Primary Children's Hospital, National Heart, Lung, and Blood Institute (NHLBI)