Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old (KL4-AHRF-01)

Inclusion Criteria:

• ≥ 38 weeks (corrected age) to 2 years (24 months)
• Intubated and mechanically ventilated (MV) for ≥ 6 hours and anticipated need for MV for ≥ 24 hours
• Persistent hypoxia
• Written informed consent

Exclusion Criteria:

• Mechanical Ventilation for > 48 hours
• Oxygenation index ≥ 25, if arterial line was avialable
• Pre-existing clinically significant or palliated/uncorrected cardiac disease adversely affecting cardiopulmonary function and gas exchange
• Neuromuscular disease or hypotonia
• Upper airway disease
• Baseline requirment for supplemental oxygen
• Untreated pneumothorax
• Off-label use of commercially available surfactant outside neonatal period
• History of prematurity and passive immunoprophylaxis with humanized monoclonal antibody
• Head injury with Glasgow Coma Scale < 8
• Brain death or impending brain death
• Do not resuscitate orders
• Cardiopulmonary resuscitation within 6 hours of meeting entry criteria
• Experimental therapy in which the intervention potentially affects respiratory outcomes
• Any transplant recipient
• Meconium aspiration syndrome
• Bordetella pertussis infection confirmed via laboratory tests and/or highly suspected pertussis infection