- ClinicalTrials.gov ID: NCT05268094
- Not accepting healthy volunteers
- UTSW Principal Investigator: SURENDRANATH REDDY VEERAM REDDY
summary
This is a prospective multicenter randomized interventional trial. Participants will be randomized to receive either an SPS or DAS. Block randomization will be performed by center and by single vs. two ventricle status. Participants will be followed through the first year of life.
objective
1. To randomize neonates with ductal-dependent pulmonary blood flow to either ductal artery stent (DAS) or surgical systemic-to pulmonary artery shunt (SPS) and to perform an intention-to-treat analysis of their outcomes. 2. To describe the failure rate for neonatal candidates for DAS and the impact of this failure on the post-SPS course.