332
Participants
Start Date
May 31, 2008
Primary Completion Date
December 31, 2010
Study Completion Date
February 28, 2011
Calfactant
Intratracheal Instillation of 0.5 mL/cm of height of 60 mg/mL suspension in two aliquots at study entry. Repeat dosing 12 hours later if criteria are met.
Room Air (placebo)
Administration of 0.5 ml/cm height of air at study entry into the trachea. Repeat dosing at 12 hours if criteria are met
University of Virginia Health Science Center, Charlottesville
Creighton University, Omaha
Omaha Children's Hospital, Omaha
University of Florida, Gainesville
Florida Hospital and Florida Children's Hospital, Orlando
Northwestern University-Chicago, Chicago
West Suburban Hospital Medical Center, Oak Park
Peoria Pulmonary Associates/OSF St. Francis Hospital, Peoria
Clarian Health, Inc/Methodist Hospital, Indianapolis
University of Iowa, Iowa City
Dartmouth-Hitchcock Medical Center, Lebanon
Columbia Medical Center--Pediatrics, New York
The Oregon Clinic, Portland
Penn State University, Hershey
Baylor College of Medicine/Texas Children's Hospital, Houston
Uthscsa/Stvah, San Antonio
INOVA Fairfax Hospital, Fairfax
Medical College of Wisconsin, Milwaukee
Royal Adelaide Hospital, Adelaide
Royal Columbian Hospital, New Westminster
British Columbia Children's Hospital, Vancouver
Surrey Memorial Hospital, Vancouver
Vancouver General Hospital, Vancouver
Kingston General Hospital, Kingston
London Health Sciences Centre, London
Ottawa Hospital, Ottawa
Haemek Medical Center, Jerusalem
Rabin Medical Center, Jerusalem
Auckland City Hospital, Auckland
Starship Children's Hospital, Auckland
Asan Medical Center, Seoul
Samsung Medical Center, Seoul
Lead Sponsor
Pneuma Pharmaceuticals Incorporated
OTHER