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NCT05547165 · ClinicalTrials.gov registry record · NA
Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants
A NA study of Ductus Arteriosus, Patent, sponsored by Nationwide Children's Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 240
- Enrollment target
- 20
- Study locations
NCT05547165: Recruiting NA study of Ductus Arteriosus, Patent, sponsored by Nationwide Children's Hospital.
NCT05547165 is a NA study of Ductus Arteriosus, Patent that is actively recruiting participants, run by Nationwide Children's Hospital. The registered enrollment target is 240 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05547165, a NA study of Ductus Arteriosus, Patent, is actively recruiting participants, sponsored by Nationwide Children's Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 240 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Ventilator free days (VFDs) are defined as the number of days that a subject is alive and free from mechanical ventilatory support. VFDs are an established respiratory outcome measure in pediatric clinical trials, and are a strong predictor of short-term and longer-term oucomes, including length of neonatal intensive care unit (NICU) stay, morbidities, and mortality.
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 |
What NCT05547165 shows while recruiting
NCT05547165 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower).
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.
NCT05547165 names 20 study sites across 15 states, led by California, Florida, Tennessee.
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.
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).
Who is sponsoring clinical trial NCT05547165?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05547165's enrollment target sits among peer trials
240 440th of 2000 higher than 1,543 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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