Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants
Start Date
2/21/2023
Completion Date
2/28/2026
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.
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
Percutaneous Patent Ductus Arteriosus Closure (PPC)
Responsive Management Intervention
Echocardiogram, cardiac
Conditions
Locations
University of Alabama
Birmingham, Alabama 35294
United States
Arkansas Children's Hospital
Little Rock, Arkansas 72202
United States
Children's Hospital Los Angeles
Los Angeles, California 90027
United States
Cedars-Sinai Medical Center
Los Angeles, California 90048
United States
Lucille Packard Children's Hospital at Stanford
Palo Alto, California 94304
United States
UC Davis Children's Hospital
Sacramento, California 95817
United States
Children's Hospital Colorado
Aurora, Colorado 80045
United States
Joe DiMaggio Children's Hospital
Hollywood, Florida 33021
United States
Orlando Health
Orlando, Florida 32806
United States
Ann and Robert H. Lurie Children's Hospital
Chicago, Illinois 60611
United States
Boston Children's Hospital
Boston, Massachusetts 02115
United States
C.S. Mott Children's Hospital
Ann Arbor, Michigan 48109
United States
University of Minnesota, Masonic Children's Hospital
Minneapolis, Minnesota 55455
United States
St. Louis Children's Hospital
St Louis, Missouri 63110
United States
Morgan Stanley Children's Hospital of New York-Presbyterian
New York, New York 10032
United States
Nationwide Children's Hospital
Columbus, Ohio 43205
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United States
Le Bonheur Children's Medical Center
Memphis, Tennessee 38103
United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee 37232
United States
Medical City Children's Dallas
Dallas, Texas 75230
United States
UT Southwestern Children's Medical Center of Dallas
Dallas, Texas 75235
United States
Texas Children's
Houston, Texas 77030
United States
Seattle Children's
Seattle, Washington 98105
United States
Children's Wisconsin
Milwaukee, Wisconsin 53226
United States