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Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants
NCT05547165 · View on ClinicalTrials.gov ↗
Study Summary
Patent Ductus Arteriosus is a developmental condition commonly observed among preterm infants. It is a condition where the opening between the two major blood vessels leading from the heart fail to close after birth. In the womb, the opening (ductus arteriosus) is the normal part of the circulatory system of the baby, but is expected to close at full term birth. If the opening is tiny, the condition can be self-limiting. If not, medications/surgery are options for treatment. There are two ways to treat patent ductus arteriosus - one is through closure of the opening with an FDA approved device called PICCOLO, the other is through supportive management (medications). No randomized controlled trials have been done previously to see if one of better than the other. Through our PIVOTAL study, the investigators aim to determine is one is indeed better than the other - if it is found that the percutaneous closure with PICCOLO is better, then it would immediately lead to a new standard of care. If not, then the investigators avoid an invasive costly procedure going forward.
Conditions Studied
Interventions
- DEVICE Percutaneous Patent Ductus Arteriosus Closure (PPC)
- COMBINATION_PRODUCT Responsive Management Intervention
- DIAGNOSTIC_TEST Echocardiogram, cardiac
Study Locations (20)
California
- Children's Hospital Los Angeles — Los Angeles
- Cedars-Sinai Medical Center — Los Angeles
- Lucille Packard Children's Hospital at Stanford — Palo Alto
- UC Davis Children's Hospital — Sacramento
Florida
- Joe DiMaggio Children's Hospital — Hollywood
- Orlando Health — Orlando
Tennessee
- Le Bonheur Children's Medical Center — Memphis
- Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville
Alabama
- University of Alabama — Birmingham
Arkansas
- Arkansas Children's Hospital — Little Rock
Colorado
- Children's Hospital Colorado — Aurora
Illinois
- Ann and Robert H. Lurie Children's Hospital — Chicago
Massachusetts
- Boston Children's Hospital — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2023-02-21 |
| Est. Completion | 2026-02-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05547165
The ClinicalTrials.gov registry entry for NCT05547165 describes a study currently listed as 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 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nationwide Children's Hospital, which has 239 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 Ductus Arteriosus, Patent appearing as the primary indexed condition, and to 3 interventions — of which Percutaneous Patent Ductus Arteriosus Closure (PPC) 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: NCT05547165 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Florida, Tennessee. 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 NCT05547165 about?
NCT05547165 is a clinical study titled "Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants". Patent Ductus Arteriosus is a developmental condition commonly observed among preterm infants. It is a condition where the opening between the two major blood vessels leading from the heart fail to close after birth. In the womb, the opening (ductus arteriosus) is the normal part of the circulatory ...
What is the current status of trial NCT05547165?
This trial is currently recruiting. It is a NA study. The enrollment target is 240 participants. The study started on 2023-02-21. Estimated completion is 2026-02-28.
What conditions does trial NCT05547165 study?
This clinical trial studies the following conditions: Ductus Arteriosus, Patent. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05547165?
The interventions under investigation include: Percutaneous Patent Ductus Arteriosus Closure (PPC) (DEVICE), Responsive Management Intervention (COMBINATION_PRODUCT), Echocardiogram, cardiac (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05547165?
This trial is sponsored by Nationwide Children's Hospital, which has 239 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05547165 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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