Pediatric calfactant in acute respiratory distress syndrome trial

Douglas F. Willson, Neal J. Thomas, Robert Tamburro, Edward Truemper, Jonathon Truwit, Mark Conaway, Christine Traul, Edmund E. Egan

55 Scopus citations

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 A total of 110 subjects were enrolled, with consent withdrawn from one whose data are unavailable.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.

Original languageEnglish (US)
Pages (from-to)657-665
Number of pages9
JournalPediatric Critical Care Medicine
Volume14
Issue number7
DOIs
Publication statusPublished - Jan 1 2013

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Keywords

  • Acute lung injury
  • Acute respiratory distress syndrome
  • Calfactant
  • Direct lung injury
  • Hypoxemia index
  • Oxygen saturation index
  • Recruitment maneuver
  • Respiratory failure
  • Surfactant

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Critical Care and Intensive Care Medicine

Cite this

Willson, D. F., Thomas, N. J., Tamburro, R., Truemper, E., Truwit, J., Conaway, M., ... Egan, E. E. (2013). Pediatric calfactant in acute respiratory distress syndrome trial. Pediatric Critical Care Medicine, 14(7), 657-665. https://doi.org/10.1097/PCC.0b013e3182917b68