Condition: Ductus Arteriosus, Patent · Sponsor: Nationwide Children's Hospital
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.
This description comes directly from the study's public registry record.
Carl H Backes · 16143556729 · carl.backes@nationwidechildrens.org
Jonathan Slaughter · 16143556643 · jonathan.slaughter@nationwidechildrens.org
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| University of Alabama | Birmingham, Alabama, United States | Recruiting |
| Arkansas Children's Hospital | Little Rock, Arkansas, United States | Recruiting |
| Children's Hospital Los Angeles | Los Angeles, California, United States | Withdrawn |
| Cedars-Sinai Medical Center | Los Angeles, California, United States | Recruiting |
| Lucille Packard Children's Hospital at Stanford | Palo Alto, California, United States | Withdrawn |
| UC Davis Children's Hospital | Sacramento, California, United States | Recruiting |
| Children's Hospital Colorado | Aurora, Colorado, United States | Withdrawn |
| Joe DiMaggio Children's Hospital | Hollywood, Florida, United States | Recruiting |
| Orlando Health | Orlando, Florida, United States | Recruiting |
| Ann and Robert H. Lurie Children's Hospital | Chicago, Illinois, United States | Recruiting |
| Boston Children's Hospital | Boston, Massachusetts, United States | Recruiting |
| C.S. Mott Children's Hospital | Ann Arbor, Michigan, United States | Withdrawn |
+ 12 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05547165