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 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.

NCT Number	NCT05547165
Lead Sponsor	Nationwide Children's Hospital Collaborators: National Institutes of Health (NIH), Abbott, University of Pittsburgh, University of Bristol, Dartmouth College, University of Iowa, Emory University, Cedars-Sinai Medical Center, Children's Hospital Los Angeles, National Heart, Lung, and Blood Institute (NHLBI)
Conditions	Ductus Arteriosus, Patent
Enrollment	240 participants
Start Date	2023-02-21
Primary Completion	2026-02-28 (estimated)
Study Completion	2026-02-28 (estimated)
Updated on ClinicalTrials.gov	2025-03-30