drugset / Trial / NCT00004500

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

NCT00004500

Phase 3 Terminated 69 enrolled Windtree Therapeutics
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2000-03
Primary completion
2002-11
Completion
2004-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Lucinactant Peptide 10 mg/ml Other