NCT00578734

Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Windtree Therapeutics · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Determine the safety and tolerability of administration of a peptide-containing synthetic lung surfactant, lucinactant, in children up to two years of age and assess whether treatment with lucinactant can decrease the duration of mechanical ventilation in young children.

Conditions

• Acute Hypoxemic Respiratory Failure

Interventions

Type	Name	Description
DRUG	Lucinactant	Slow intra-tracheal instillation
OTHER	Sham Comparator	Slow intra-tracheal instillation

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2007-12-21
• Last updated: 2012-05-03
• Results posted: 2012-04-27

Locations

3 sites across 2 countries: United States, Chile