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

A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Efficacy of SURFAXIN® (Lucinactant), in Very Low Birth Weight (VLBW) Infants at Risk for Developing Bronchopulmonary Dysplasia

SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia (BPD), in premature infants who have required continued intubation and received surfactants for the prevention or treatment of respiratory distress syndrome (RDS).

Determine the safety and tolerability of SURFAXIN administration in the first weeks of life as a therapeutic approach for prevention of BPD. Determine whether treatment with SURFAXIN during the first two to three weeks of life can decrease the proportion of infants on mechanical ventilation or oxygen or the incidence of death or BPD in VLBW infants when assessed at 28 days of life and 36 weeks post-menstrual age (as determined by the need for supplemental oxygen).

Inclusion Criteria:

• Premature infants between 600 and 900 grams birth weight
• Intubated and on mechanical ventilation
• Sustained (>= 30 minutes) fraction of inspired oxygen (FiO₂) >= 0.30 within 8 hours prior to randomization

Exclusion Criteria:

• Mother has prolonged rupture of membranes ≥ 2 weeks
• Culture-proven sepsis
• High grade intraventricular hemorrhage (IVH)
• Congenital heart disease
• Congential anomalies inconsistent with life or likely to confound efficacy or safety endpoints
• FiO₂≥ 0.80 and mean airway pressure (MAP) ≥ 12 cmH2O at day of life (DOL) 3
• FiO₂< 0.25 at any time between meeting the entry criteria to immediately prior to randomization
• Concomitant use of any other surfactant within the first 48 hours of life
• Prior use of nitric oxide
• Prior use of steroids
• Current participation in any other clinical trial or has received an experimental drug or used an experimental device