Fetal Cerebrovascular Autoregulation in Congenital Heart Disease and Association With Neonatal Neurobehavior
Recruiting
Phase 2
Phase 3
Interventional Study
Congenital Heart Disease in Children
Hypoxia
Neurodevelopmental Disorders
Complex Congenital Heart Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 0 – 52
- Sex
- Female
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 150 (estimated)
- Sponsor
- University of Utah · Other
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About This Trial
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 approache…
Trial Locations
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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 pr…
Contacts