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

• Status: Terminated
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Windtree Therapeutics
• Treatments: Pulmonary Surfactants

Criteria

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