Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2020
Preterm infants diagnosed with a hemodynamically‐significant patent ductus arteriosus (HSPDA) will be included. Specific criteria will be followed to determine if a patent ductus arteriosus (PDA) is "hemodynamically significant". Infants will be randomized to two different approaches for management of the PDA. The first will be catheter‐based closure (intervention) and the second will be conservative management (non‐intervention). Both procedures are standard practice at many institutions, including Nationwide Children's Hospital. Infants randomized to receive intervention will undergo a procedure in which a catheter is used to place an FDA‐approved device within the PDA, to close it (like a plug). Infants randomized to the conservative management (non‐intervention) group will be permitted time to see if the PDA closes on its own, naturally. However, if the PDA remains open and intervention is deemed medically necessary, they will also undergo the catheter closure procedure.
Epistemonikos ID: c60e478beaa0bc9a19d6d083d59306bba0824d5b
First added on: May 22, 2024