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Effect of exogenous surfactant (calfactant) in pediatric acute lung injury: a randomized controlled trial
Douglas F Willson1, Neal J Thomas, Barry P Markovitz
1Department of Pediatrics, University of Virginia Health System, Children's Medical Center, Charlottesville, VA 22908, USA. dfw4m@virginia.edu
Insights
Calfactant improved oxygenation and decreased mortality in pediatric acute lung injury (ALI) patients, but did not shorten respiratory failure duration. This study offers hope for ALI treatment in young patients.
Area of Science:
- Pediatric critical care medicine
- Pulmonology
- Neonatology
Background:
- Acute lung injury (ALI) in children is associated with surfactant dysfunction.
- Previous trials of surfactant therapy in adult ALI have been unsuccessful.
- Preliminary studies suggest natural lung surfactant (calfactant) may benefit pediatric ALI.
Purpose of the Study:
- To evaluate the efficacy of endotracheal calfactant instillation in infants, children, and adolescents with ALI.
- To determine if calfactant treatment shortens the duration of respiratory failure in pediatric ALI patients.
Main Methods:
- A multicenter, randomized, blinded trial comparing calfactant to placebo in 153 pediatric ALI patients.
- Patients received two doses of calfactant or air placebo 12 hours apart.
- Key outcomes included ventilator-free days and mortality; secondary outcomes assessed hospital course and mechanical ventilation response.
Main Results:
- Calfactant significantly improved oxygenation acutely post-administration (P = .01).
- Mortality was significantly lower in the calfactant group compared to placebo (OR, 2.32; 95% CI, 1.15-4.85).
- No significant differences were observed in ventilator-free days, intensive care unit stay, or hospital stay.
Conclusions:
- Calfactant demonstrates acute benefits in oxygenation and reduces mortality in pediatric ALI.
- Calfactant did not significantly shorten the course of respiratory failure in this pediatric population.
- Further research may explore optimal dosing or patient selection for calfactant therapy in ALI.
Context:
Despite evidence that patients with acute lung injury (ALI) have pulmonary surfactant dysfunction, trials of several surfactant preparations to treat adults with ALI have not been successful. Preliminary studies in children with ALI have shown that instillation of a natural lung surfactant (calfactant) containing high levels of surfactant-specific protein B may be beneficial.
Objective:
To determine if endotracheal instillation of calfactant in infants, children, and adolescents with ALI would shorten the course of respiratory failure.
Design, Setting, And Patients:
A multicenter, randomized, blinded trial of calfactant compared with placebo in 153 infants, children, and adolescents with respiratory failure from ALI conducted from July 2000 to July 2003. Twenty-one tertiary care pediatric intensive care units participated. Entry criteria included age 1 week to 21 years, enrollment within 48 hours of endotracheal intubation, radiological evidence of bilateral lung disease, and an oxygenation index higher than 7. Premature infants and children with preexisting lung, cardiac, or central nervous system disease were excluded.
Intervention:
Treatment with intratracheal instillation of 2 doses of 80 mL/m2 calfactant or an equal volume of air placebo administered 12 hours apart.
Main Outcome Measures:
Ventilator-free days and mortality; secondary outcome measures were hospital course, adverse events, and failure of conventional mechanical ventilation.
Results:
The calfactant group experienced an acute mean (SD) decrease in oxygenation index from 20 (12.9) to 13.9 (9.6) after 12 hours compared with the placebo group's decrease from 20.5 (14.7) to 15.1 (9.0) (P = .01). Mortality was significantly greater in the placebo group compared with the calfactant group (27/75 vs 15/77; odds ratio, 2.32; 95% confidence interval, 1.15-4.85), although ventilator-free days were not different. More patients in the placebo group did not respond to conventional mechanical ventilation. There were no differences in long-term complications.
Conclusions:
Calfactant acutely improved oxygenation and significantly decreased mortality in infants, children, and adolescents with ALI although no significant decrease in the course of respiratory failure measured by duration of ventilator therapy, intensive care unit, or hospital stay was observed.
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