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Pediatr Crit Care Med. 2013 Sep;14(7):657-65. doi: 10.1097/PCC.0b013e3182917b68.

Pediatric calfactant in acute respiratory distress syndrome trial.

Author information

1
1Department of Pediatrics, University of Virginia Health Sciences System, Charlottesville, VA. 2Department of Pediatrics, Penn State Hershey M.S. Hershey Medical Center, Hershey, PA. 3Department of Pediatrics, Children's Hospital & Medical Center, University of Nebraska, Omaha, NE. 4Department of Internal Medicine, University of Virginia Health Sciences System, Charlottesville, VA. 5Public Health Sciences, University of Virginia Health Sciences System, Charlottesville, VA. 6Department of Pediatrics, Children's Hospital Cleveland Clinic, Cleveland, OH. 7Pneuma Pharmaceuticals, Amherst, NY. 8Department of Pediatrics, State University of New York at Buffalo, Buffalo, NY.

Abstract

RATIONALE:

Our previous studies in children with acute lung injury/acute respiratory distress syndrome demonstrated improved outcomes with exogenous surfactant (calfactant) administration. Sample sizes in those studies were small, however, and the subject populations heterogeneous, thus making recommendations tenuous.

OBJECTIVE:

To investigate the efficacy of surfactant administration in a larger, more homogenous population of children with lung injury/acute respiratory distress syndrome due to direct lung injury.

DESIGN AND SETTING:

Masked, randomized, placebo-controlled trial in 24 children's hospitals in six different countries.

PATIENTS AND METHODS:

Children 37 weeks postconception to 18 years old with lung injury/acute respiratory distress syndrome due to direct lung injury were randomized to receive up to three doses of 30 mg/cm height of surfactant (calfactant) versus placebo (air) within 48 hours of intubation and initiation of mechanical ventilation. The primary outcome was mortality at 90 days. Ventilator-free days, changes in oxygenation, and adverse events were also assessed.

RESULTS:

The study was stopped at the sponsor's request after the second interim analysis for presumed futility. A total of 110 subjects were enrolled, with consent withdrawn from one whose data are unavailable. There were no significant differences between groups except in hospital-free days (10.4 ± 7.8 placebo vs 6.4 ± 7.8 surfactant; p = 0.01). Overall 90-day mortality was 11% (seven surfactant, five placebo). No immediate improvement in oxygenation was associated with surfactant administration.

CONCLUSIONS:

Surfactant did not improve outcomes relative to placebo in this trial of children with direct lung injury/acute respiratory distress syndrome. Differences in concentration of the surfactant, failure to recruit the lung during surfactant administration, or using two rather than four position changes during administration are possible explanations for the difference from previous studies. Exogenous surfactant cannot be recommended at this time for children with direct lung injury/acute respiratory distress syndrome.

Comment in

PMID:
23846250
DOI:
10.1097/PCC.0b013e3182917b68
[Indexed for MEDLINE]
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