Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome

Inclusion Criteria: * Diagnosis of meconium aspiration syndrome (MAS) * Continuous mechanical ventilation (CMV) at time of entry * Enrollment within 48 hours of birth * Gestational age of ≥ 37 weeks * Oxygenation index of ≥ 5 and ≤ 30 * Written informed consent signed and dated by the infant's parent(s) or legal guardian(s) Exclusion Criteria: * Congenital anomalies likely to affect any primary or secondary endpoints * Uncontrollable air leaks * Hydrops fetalis * Rupture ≥ 3 weeks of the fetal membranes * Evidence of overwhelming bacterial infection at time of randomization * Markedly labile persistent pulmonary hypertension at time of randomization * Profound neurologic manifestations * Sustained postductal SpO₂of \< 87% for ≥ 15 minutes at an FiO₂of 1.00