Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants (NCT05547165)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (16 items).
Location: University of Alabama — Birmingham, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria: Clinical Exclusion Criteria
- Life-threatening congenital defects (including congenital heart disease such as aortic coarctation or pulmonary artery stenosis). PDA and small atrial/ventricular septal defects are permitted;
- Congenital lung abnormalities, (e.g. restrictive lung disease);
- Pharyngeal or airway anomalies (tracheal stenosis, choanal atresia);
- Treatment for acute abdominal process (e.g., necrotizing enterocolitis);
- Infants with planned surgery;
- Active infection requiring treatment;
- Chromosomal defects (e.g., Trisomy 18);
- Neuromuscular disorders;
- Infants whose parents have chosen to allow natural death (do not resuscitate order) or for whom limitation of intensive care treatment is being considered (e.g. severe intraventricular hemorrhage)
- Physician deems that the infant would not be a Percutaneous PDA Closure candidate due to clinical instability; however, if the infant's clinical status improves before 30-days postnatal and all inclusion criteria are still met, then the infant may be enrolled. ECHO-based Exclusion Criteria
- Pulmonary hypertension (defined by ductal right to left shunting for \>33% of the cardiac cycle) in which early PDA closure may increase right ventricular afterload and compromise pulmonary and systemic blood flow;
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (24 Sites)
- University of Alabama — Birmingham, Alabama
- Arkansas Children's Hospital — Little Rock, Arkansas
- Children's Hospital Los Angeles — Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California
- Lucille Packard Children's Hospital at Stanford — Palo Alto, California
- UC Davis Children's Hospital — Sacramento, California
- Children's Hospital Colorado — Aurora, Colorado
- Joe DiMaggio Children's Hospital — Hollywood, Florida
- Orlando Health — Orlando, Florida
- Ann and Robert H. Lurie Children's Hospital — Chicago, Illinois
- Boston Children's Hospital — Boston, Massachusetts
- C.S. Mott Children's Hospital — Ann Arbor, Michigan
- University of Minnesota, Masonic Children's Hospital — Minneapolis, Minnesota
- St. Louis Children's Hospital — St Louis, Missouri
- Morgan Stanley Children's Hospital of New York-Presbyterian — New York, New York
- Nationwide Children's Hospital — Columbus, Ohio
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- Le Bonheur Children's Medical Center — Memphis, Tennessee
- Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee
- Medical City Children's Dallas — Dallas, Texas
- UT Southwestern Children's Medical Center of Dallas — Dallas, Texas
- Texas Children's — Houston, Texas
- Seattle Children's — Seattle, Washington
- Children's Wisconsin — Milwaukee, Wisconsin
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.