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 (KL4-AHRF-01)

NCT00578734 Phase 2 COMPLETED Results posted

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).

Details

Lead sponsor	Windtree Therapeutics
Phase	Phase 2
Status	COMPLETED
Enrolment	165
Start date	2007-06
Completion	2010-04

Conditions

• Acute Hypoxemic Respiratory Failure

Interventions

• Lucinactant
• Sham Comparator

Primary outcomes

• Duration of Mechanical Ventilation Through 14 Days — Up to 14 Days
  Duration of mechanical ventilation (MV) from baseline to successful extubation (not receiving MV for at least 24 hours) through a maximum of 14 days.

Countries

United States, Chile