At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 165 enrolled
Drug / intervention
Lucinactant +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Masked, Placebo-Controlled Trial to Assess the Safety and Efficacy of Lucinactant in Acute Hypoxemic Respiratory Failure in Children Up to Two Years of Age
In Brief
A Phase 2 clinical trial evaluating Lucinactant and Sham Comparator for Acute Hypoxemic Respiratory Failure. Completed, enrolled 165 participants across 3 sites in 2 countries.
Detailed Summary
Treatment with lucinactant, a peptide-containing synthetic lung surfactant, will be evaluated in young children with acute respiratory failure who require mechanical ventilation (life support), to determine if it is safe and if treatment with lucinactant will reduce the number of days a child needs mechanical ventilation (life support).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Hypoxemic Respiratory Failure
CountriesChile, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2007
First PostedDec 2007
Primary CompletionApr 2010
TodayJul 2026
First PostedDec 21, 2007
Enrollment StartJun 1, 2007
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.5 years ago
Interventions
Lucinactantdrug
Slow intra-tracheal instillation
Sham Comparatorother
Slow intra-tracheal instillation