Conditions: Acute Hypoxemic Respiratory Failure
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 165
Healthy volunteers: no

Brief 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.

Arms:
arm 1: SURFAXIN® (lucinactant) for intratracheal instillation arm 2: Sham air (placebo) instillation

Interventions: intervention 1: Lucinactant intervention 2: Sham Comparator
Intervention descriptions: intervention 1: Slow intra-tracheal instillation intervention 2: Slow intra-tracheal instillation

Protocol document: