451
Participants
Start Date
November 30, 2009
Primary Completion Date
May 31, 2013
Study Completion Date
May 31, 2014
Inhaled Nitric Oxide
Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
Placebo
Nitrogen gas will be administered in the same manner as the experimental drug.
Montefiore Medical Center, The Bronx
Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla
Winthrop University Hospital, Mineola
Virginia Commonwealth University, Richmond
WakeMed Faculty Physicians, Neonatology, Raleigh
Greenville Memorial Hospital, Greenville
Medical College of Georgia, Augusta
Winnie Palmer Hospital for Women and Babies, Orlando
University of So Florida College of Medicine, Tampa
University of Louisville School of Medicine, Louisville
Mercy Children's Hospital, Toledo
Riley Hospital for Children, Indianapolis
Wheaton Franciscan Healthcare, Milwaukee
Children's Corporate Center, Division of Neonatology, Wauwatosa
Hennepin County Medical Center, Minneapolis
Sanford Children's Hospital, Sioux Falls
Advocate Lutheran General Children's Hospital, Park Ridge
Saint Francis Children's Hospital, Tulsa
Cook Children's Medical Center, Fort Worth
Primary Children's Medical Center, Salt Lake City
Phoenix Children's Hospital, Phoenix
St. Joseph's Hospital and Medical Center, Phoenix
Rady Children's Hospital of San Diego, San Diego
Sharp Mary Birch Hospital for Women and Newborns, San Diego
Loma Linda University School of Medicine, Loma Linda
Children's Hospital of Orange County, Orange
Stanford University School of Medicine, Palo Alto
Connecticut Children's Medical Center, Hartford
Saint Barnabas Medical Center, Livingston
Jersey Shore University Medical Center, Neptune City
Robert Wood Johnson University Hospital, New Brunswick
University of Calgary, Calgary
Centre Hospitalier Universitaire de Quebec, Québec
Lead Sponsor
Mallinckrodt
INDUSTRY