22
Participants
Start Date
January 31, 2000
Primary Completion Date
June 30, 2002
Study Completion Date
December 31, 2003
recombinant human CC10 (rhCC10)
5 mg/kg rhCC10, single dose delivered intratracheally (IT). Treatment was delivered within four hours after surfactant treatment. Dose was delivered IT in two (2) equal aliquots via a premeasured feeding tube placed in the distal third of the endotracheal tube with the patient in the right and then left lateral decubitus position and 30 degrees of Trendelenburg.
recombinant human CC10 (rhCC10)
1.5 mg/kg rhCC10, single dose delivered intratracheally (IT). Treatment was delivered within four hours after surfactant treatment. Dose was delivered IT in two (2) equal aliquots via a premeasured feeding tube placed in the distal third of the endotracheal tube with the patient in the right and then left lateral decubitus position and 30 degrees of Trendelenburg
placebo
Half normal saline solution; single dose delivered intratracheally (IT). Treatment was delivered within four hours after surfactant treatment. Dose was delivered IT in two (2) equal aliquots via a premeasured feeding tube placed in the distal third of the endotracheal tube with the patient in the right and then left lateral decubitus position and 30 degrees of Trendelenburg.
Winthrop-University Hospital, SUNY Stony Brook School of Medicine, Mineola
Christiana HealthCare Systems, Wilmington
University of Maryland School of Medicine, Baltimore
Mercy Medical Center, Baltimore
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Clarassance, Inc.
INDUSTRY