A Multinational, Multicenter, Masked, Randomized, Controlled Study to Assess The Safety and Efficacy of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age With Respiratory Distress Syndrome
The primary objective of this study is to evaluate the safety and efficacy of lucinactant for inhalation administered as an aerosolized dose in two doses to preterm neonates 26 - 32 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for Resipiratory Distress Syndrome (RDS) compared to neonates receiving nCPAP alone.
-26 to 32 completed weeks post menstrual age (PMA).
-Chest radiograph consistent with RDS.
-Within the first 20 hours after birth, respiratory insufficiency requiring an nCPAP of 5 to 6 cm H2O to maintain SpO2 of 90% to 95%, with an FiO2 of 0.25 to 0.45 that is clinically indicated for at least 30 minutes. Transient (<10 minutes) FiO2 excursions below 0.25 or above 0.45 do not reset the 30-minute requirement.
**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
Joseph Kaempf MD
- Providence St. Vincent Medical Center