A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age

Inclusion Criteria: * Signed ICF from legally authorized representative. * Gestational age: 26 to 32+6 weeks PMA. * Successful implementation of non-invasive support or ventilation within 30 minutes after birth. * Spontaneous breathing. * Investigator determination of RDS. A chest x-ray should be obtained before treatment to confirm the diagnosis. * Within the first 6 hours after birth, requires an nCPAP of 5 to 7 cm H2O that is clinically indicated for at least 15 minutes with an FiO2 \> 0.25 to ≤ 0.35 to maintain SpO2 of 90% to 95%. Exclusion Criteria: * A heart rate that cannot be stabilized above 100 bpm within 5 minutes of birth. * Recurrent episodes of apnea requiring positive pressure ventilation. * A 5 minute Apgar score \< 5. * Major congenital malformation(s) or craniofacial abnormalities that preclude the use of nCPAP. * Clinically significant diseases or conditions other than RDS which could potentially interfere with cardiopulmonary function. * A known or suspected chromosomal abnormality or syndrome. * Premature rupture of membranes \> 3 weeks. * Hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis. * A need for intubation and/or invasive mechanical ventilation at any time before enrollment into the study. * The administration (or plan for administration) of another investigational agent or investigational medical device, any other surfactant agent, or systemic corticosteroids. * Presence of air le…