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

A Multicenter, Randomized, Controlled Trial Comparing the Safety and Effectiveness of Bronchoalveolar Lavage With Lucinactant to Standard Care for the Treatment of the Meconium Aspriation Syndrome (MAS) in Newborn Infants

OBJECTIVES:

Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.

PROTOCOL OUTLINE:

This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.

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 2 courses.

Arm II: Patients receive standard treatment including oxygen, conventional mechanical ventilation, sedation, paralysis, vasopressors, and alkalinization.

Patients are followed for 12 months.

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