Percutaneous Intervention Versus Observational Trial of ArterialDuctus in Low weight Infants (PIVOTAL)

This study is called * PIVOTAL, * which stands for Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low weight Infants. PIVOTAL compares 2 different ways to treat infants born early (premature) with a patent ductus arteriosus (known as a PDA). A PDA is a blood vessel connecting the lungs and the heart. All infants have a PDA when they are born. Most PDAs close shortly after birth. In premature infants, the PDA can stay * open. * Open PDAs may cause breathing problems. Infants born early (more than 12 weeks before the planned delivery date), who need help breathing using a machine (ventilator), and who have an open PDA may qualify for this study. PIVOTAL compares 2 ways to treat an open PDA after the first weeks of life: 1) Catheter Closure: the PDA will be closed with an FDA approved device called Piccolo that is inserted with a small flexible tube called a “catheter[Single Quote] 2) Responsive Management: this would manage the symptoms caused by the PDA, which may include medications and changes in fluid amounts given to your infant These are two options for infants born with an open PDA. We do not know which treatment approach is best for infants with open PDAs. Both treatment approaches in this study are considered * best practice * and * standard of care. * The medical team agrees that the overall possible benefits and risks balance out across both treatment approaches. This study is needed to determine which way is best to treat infants with open PDAs within the first weeks of life for best possible health outcomes. Infants will be randomized to either Catheter Closure or Responsive Management.