800
Participants
Start Date
August 11, 2011
Primary Completion Date
September 21, 2020
Study Completion Date
September 12, 2024
Hydrocortisone
"Hydrocortisone sodium succinate for intravenous administration (unpreserved, Solu-Cortef plain, Pfizer®, reconstituted with unpreserved normal saline to avoid exposure to the benzyl alcohol contained in preserved diluents), to be administered either intravenously or orally if no intravenous line is available at the same dose, and tapered as follows:~4mg/kg/day ¸ q 6 hours x 2 days, then 2mg/kg/day ¸ q 6 hours x 3 days; then~1mg/kg/day ¸ q 12 hours x 3 days; then 0.5mg/kg/d as a single dose x 2 days"
Placebo
"Saline placebo to be administered either intravenously or orally if no intravenous line is available, at the same dose, and tapered as follows:~4mg/kg/day ¸ q 6 hours x 2 days, then 2mg/kg/day ¸ q 6 hours x 3 days; then~1mg/kg/day ¸ q 12 hours x 3 days; then 0.5mg/kg/d as a single dose x 2 days"
University of Rochester, Rochester
Univeristy of Pennsylvania, Philadelphia
RTI International, Durham
Duke University, Durham
Emory University, Atlanta
University of Alabama at Birmingham, Birmingham
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
Indiana University, Indianapolis
Wayne State University, Detroit
University of Iowa, Iowa City
Children's Mercy Hospital, Kansas City
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
University of California - Los Angeles, Los Angeles
Stanford University, Palo Alto
Brown University, Women & Infants Hospital of Rhode Island, Providence
National Center for Research Resources (NCRR)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Center for Advancing Translational Sciences (NCATS)
NIH
NICHD Neonatal Research Network
NETWORK