941
Participants
Start Date
December 31, 2013
Primary Completion Date
February 28, 2019
Study Completion Date
February 28, 2020
Epo
Enrollment will occur within 24 hours of birth. Study drug will be administered intravenously for the first 6 doses. Subjects in the Epo arm will then receive 400 U/kg/dose three times a week until they reach 32-6/7 weeks postmenstrual age. Control infants will receive sham injections.
Control
Subjects will receive 6 doses of vehicle intravenously during the first 2 weeks of life. Doses will be administered at 48 hour intervals from the time of enrollment. Following high dose administration, sham subcutaneous injections will be given three times a week through to 32-6/7 weeks postmenstrual age.
Maia Fareri Children's Hospital, Valhalla
Johns Hopkins, Baltimore
Wake Forest School of Medicine, Winston-Salem
University of Florida, Gainesville
Florida Hospital, Orlando
South Miami Hospital, Miami
All Childrens Hospital, St. Petersburg
University of Louisville, Louisville
Children's Hospital of Minnesota, St. Paul, Saint Paul
Children's Hospital of Minnesota, MN, Minneapolis
University of Minnesota Amplatz Children's Hospital, Minneapolis
Prentice Women's Hospital, Chicago
Children's Hospital of the University of Illinois, Chicago
University of Arkansas, Little Rock
Methodist Children's Hospital, San Antonio
University of Utah, Salt Lake City
University of New Mexico Children's Hospital, Albuquerque
University of Washington, Seattle
Beth Israel Deaconess Hospital, Boston
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Washington
OTHER