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Calfactant for ALI in Pediatric Leukemia and HSCT
NCT00999713Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2010
- Primary completion
- Sep 2015
- Countries
- 2
- Sponsor
- Penn State Health Milton S. Hershey Medical Center
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- calfactant
- Conditions
- acute lung injury (ALI)
01
Overview
Phase 3, randomised, double-blind trial in acute lung injury (ALI) comparing Calfactant with Placebo (air) (2 arms). Primary endpoint: All-cause Mortality at the Time of Pediatric Intensive Care Unit (PICU) Discharge up to 120 days. Started Jun 2010; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Calfactant
Endotracheal calfactant administration
Placebo (air)
Endotracheal air administration
03
Who it enrols
Pediatric and young adult patients (18 months to 25 years) with leukemia, lymphoma, or HSCT recipients who have acute lung injury requiring mechanical ventilation with an Oxygenation Index between 13 and 37.
04
Endpoints
Primary
All-cause Mortality at the Time of Pediatric Intensive Care Unit (PICU) Discharge
Secondary
Ventilator Free Days
Total Duration of Stay Required
Change in Oxygenation: First and Second Intervention
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