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Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial)
NCT05268094 · View on ClinicalTrials.gov ↗
Study Summary
COMPASS is a prospective multicenter randomized interventional trial. Participants with ductal-dependent pulmonary blood flow will be randomized to receive either a systemic-to-pulmonary artery shunt or ductal artery stent. Block randomization will be performed by center and by single vs. two ventricle status. Participants will be followed through the first year of life.
Conditions Studied
Interventions
- DEVICE Ductal Arterial Stent
- PROCEDURE Systemic-to-Pulmonary Artery Shunt
Study Locations (20)
California
- Children's Hospital Los Angeles — Los Angeles
- UCSF Benioff Children's Hospitals — Oakland
- Stanford Children's Health — Palo Alto
Pennsylvania
- Children's Hospital of Philadelphia — Philadephia
- University of Pittsburgh Medical Center — Pittsburgh
Alabama
- University of Alabama — Birmingham
Arizona
- Phoenix Children's Hospital — Phoenix
Colorado
- Children's Hospital of Colorado — Aurora
District of Columbia
- Children's National Medical Center — Washington D.C.
Florida
- Joe DiMaggio Children's Hospital — Hollywood
Georgia
- Children's Healthcare of Atlanta — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2022-06-02 |
| Est. Completion | 2028-02-29 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05268094
The ClinicalTrials.gov registry entry for NCT05268094 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Carelon Research, which has 10 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Congenital Heart Disease in Children appearing as the primary indexed condition, and to 2 interventions — of which Ductal Arterial Stent is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05268094 reports 20 study locations spanning 17 distinct geographic areas — top geographies include California, Pennsylvania, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05268094 about?
NCT05268094 is a clinical study titled "Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial)". COMPASS is a prospective multicenter randomized interventional trial. Participants with ductal-dependent pulmonary blood flow will be randomized to receive either a systemic-to-pulmonary artery shunt or ductal artery stent. Block randomization will be performed by center and by single vs. two ventri...
What is the current status of trial NCT05268094?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2022-06-02. Estimated completion is 2028-02-29.
What conditions does trial NCT05268094 study?
This clinical trial studies the following conditions: Congenital Heart Disease in Children. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05268094?
The interventions under investigation include: Ductal Arterial Stent (DEVICE), Systemic-to-Pulmonary Artery Shunt (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05268094?
This trial is sponsored by Carelon Research, which has 10 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05268094 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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