Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants
Public ClinicalTrials.gov record NCT05547165. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05547165
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 240 participants
Conditions and interventions
Conditions
Interventions
- Percutaneous Patent Ductus Arteriosus Closure (PPC) Device
- Responsive Management Intervention Combination Product
- Echocardiogram, cardiac Diagnostic Test
Device · Combination Product · Diagnostic Test
Eligibility (public fields only)
- Age range
- 7 Days to 32 Days
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 20, 2023
- Primary completion
- Feb 27, 2026
- Completion
- Feb 27, 2026
- Last update posted
- Mar 29, 2025
2023 – 2026
United States locations
- U.S. sites
- 24
- U.S. states
- 17
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | Recruiting |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | Recruiting |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | Withdrawn |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | Recruiting |
| Lucille Packard Children's Hospital at Stanford | Palo Alto | California | 94304 | Withdrawn |
| UC Davis Children's Hospital | Sacramento | California | 95817 | Recruiting |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | Withdrawn |
| Joe DiMaggio Children's Hospital | Hollywood | Florida | 33021 | Recruiting |
| Orlando Health | Orlando | Florida | 32806 | Recruiting |
| Ann and Robert H. Lurie Children's Hospital | Chicago | Illinois | 60611 | Recruiting |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | Recruiting |
| C.S. Mott Children's Hospital | Ann Arbor | Michigan | 48109 | Withdrawn |
| University of Minnesota, Masonic Children's Hospital | Minneapolis | Minnesota | 55455 | Withdrawn |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | Recruiting |
| Morgan Stanley Children's Hospital of New York-Presbyterian | New York | New York | 10032 | Withdrawn |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | Recruiting |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | Withdrawn |
| Le Bonheur Children's Medical Center | Memphis | Tennessee | 38103 | Recruiting |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | Withdrawn |
| Medical City Children's Dallas | Dallas | Texas | 75230 | Recruiting |
| UT Southwestern Children's Medical Center of Dallas | Dallas | Texas | 75235 | Recruiting |
| Texas Children's | Houston | Texas | 77030 | Recruiting |
| Seattle Children's | Seattle | Washington | 98105 | Recruiting |
| Children's Wisconsin | Milwaukee | Wisconsin | 53226 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05547165, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 29, 2025 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05547165 live on ClinicalTrials.gov.