836
Participants
Start Date
February 22, 2019
Primary Completion Date
March 2, 2025
Study Completion Date
May 30, 2027
Active Treatment
Infants assigned to the active treatment group will receive indomethacin or ibuprofen per their local site usual care dosing and schedule if the infant has a sPDA. The choice of indomethacin or ibuprofen will be left to the center, however, infants may only receive one or the other. If the infant receives both, it will be considered a protocol violation.
Expectant Management
Infants assigned to the expectant management group will receive indomethacin or ibuprofen if cardiopulmonary compromise occurs.
University of Rochester, Rochester
University of Pennsylvania, Philadelphia
RTI International, Durham
Duke University, Durham
Emory University, Atlanta
University of Alabama at Birmingham, Birmingham
University of Mississippi Medical Center - Children's of Mississippi, Jackson
Research Institute at Nationwide Children's Hospital, Columbus
Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland
Cincinnati Children's Medical Center, Cincinnati
University of Iowa, Iowa City
Northwestern Lurie Children's Hospital of Chicago, Chicago
University of Texas Southwestern Medical Center at Dallas, Dallas
University of Texas Health Science Center at Houston, Houston
University of Utah, Salt Lake City
University of New Mexico, Albuquerque
Sharp Mary Birch Hospital for Women & Newborns, San Diego
Stanford University, Palo Alto
Brown University - Women and Infants Hospital of Rhode Island, Providence
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
NICHD Neonatal Research Network
NETWORK