Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL)
in the treatment of meconium aspiration syndrome (MAS) in newborn infants.
This is a randomized, multicenter study. Patients are randomized to one of two treatment
Arm I: Patients receive lucinactant by bronchoalveolar lavage, into the right and left lung,
followed by lung drainage. Treatment repeats when patient stabilizes or every 15 minutes for
Arm II: Patients receive standard treatment including oxygen, conventional mechanical
ventilation, sedation, paralysis, vasopressors, and alkalinization.
Patients are followed for 12 months.
- 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
- 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