Safety, Pk and Anti-inflammatory Effects of CC10 Protein in Premature Infants With Respiratory Distress Syndrome (RDS)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

January 31, 2000

Primary Completion Date

June 30, 2002

Study Completion Date

December 31, 2003

Conditions
Respiratory Distress Syndrome in Premature InfantBronchopulmonary Dysplasia
Interventions
DRUG

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.

DRUG

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

DRUG

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.

Trial Locations (4)

11501

Winthrop-University Hospital, SUNY Stony Brook School of Medicine, Mineola

19899

Christiana HealthCare Systems, Wilmington

21201

University of Maryland School of Medicine, Baltimore

21202

Mercy Medical Center, Baltimore

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Clarassance, Inc.

INDUSTRY