Acute Lung Injury Clinical Trial
Official title:
A Phase 3 Trial of Calfactant for ALI in Pediatric Leukemia and HSCT Patients
Acute lung injury (ALI) is a common, life-threatening complication among pediatric leukemia
and lymphoma and hematopoietic stem cell transplant (HSCT) recipients. Although these
children represent a relatively small and unique patient population, they account for the
largest proportion of deaths of all pediatric diseases. The long-term goal of this project is
to improve outcomes among these patients. Recently, the intratracheal administration of
calfactant has resulted in decreased mortality among children with ALI including promising
results among children with cancer and following HSCT. Consequently, the primary specific aim
of this study is to assess the effect of calfactant on intensive care (PICU) survival among
pediatric leukemia and lymphoma and HSCT patients with ALI. Secondary aims include assessment
of the effect of calfactant on oxygenation and on the length of mechanical ventilation, PICU
stay, and hospital stay. Calfactant therapy has been found to be of benefit in acute lung
injury in the overall pediatric population by improving oxygenation and decreasing mortality.
These findings, in conjunction with recent subgroup analysis in which calfactant therapy
appeared to improve outcomes in immunocompromised children provide the rationale for
assessing calfactant therapy in this patient population.
Funding Source - FDA Office of Orphan Products Development (OOPD)
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