SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.

PHASE2TerminatedINTERVENTIONAL
Enrollment

136

Participants

Timeline

Start Date

February 28, 2005

Primary Completion Date

July 31, 2006

Study Completion Date

July 31, 2006

Conditions
Respiratory Distress Syndrome, NewbornPremature BirthBronchopulmonary Dysplasia
Interventions
DRUG

Lucinactant 175 mg/kg

Administered via slow intra-tracheal instillation at a dose of 175 mg/kg (5.8 mL/kg of a 30-mg/mL suspension). Initial treatment given no later than 1 hour after randomization. Additional treatments were administered every 48 hours up to a maximum of 5 doses (up to day of life (DOL) 18).

DRUG

Lucinactant 90 mg/kg

Administered via slow intra-tracheal instillation at a dose of 90 mg/kg (3.0 mL/kg of a 30-mg/mL suspension). Initial treatment given no later than 1 hour after randomization. Additional treatments were administered every 48 hours up to a maximum of 5 doses (up to DOL 18).

DRUG

Placebo

Sham air was administered via slow intratracheal instillation at a dose of 3.0 mL/kg volume of air. The initial treatment was given no later than 1 hour after randomization. Additional treatment were administered every 48 hours up to a maximum of 5 doses (up to DOL 18).

Trial Locations (1)

18976-3646

Discovery Laboratories, Inc., Warrington

Sponsors
All Listed Sponsors
lead

Windtree Therapeutics

INDUSTRY

NCT00215540 - SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants. | Biotech Hunter | Biotech Hunter