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

• Status: Terminated
• Trial end date: 2004-11-01
• Target enrollment: 0
• Participant gender: All

Summary

OBJECTIVES:

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Windtree Therapeutics
• Treatments: Pulmonary Surfactants

Criteria

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