• Pediatr Crit Care Me · Sep 2008

    Randomized Controlled Trial Multicenter Study

    Post hoc analysis of calfactant use in immunocompromised children with acute lung injury: Impact and feasibility of further clinical trials.

    • Robert F Tamburro, Neal J Thomas, Steven Pon, Brian R Jacobs, Joseph V Dicarlo, Barry P Markovitz, Larry S Jefferson, Douglas F Willson, and Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network.
    • Department of Pediatrics, Division of Pediatric Critical Care Medicine, Penn State Children's Hospital, The Pennsylvania State University College of Medicine, Hershey, PA, USA. rtamburropsu.edu
    • Pediatr Crit Care Me. 2008 Sep 1;9(5):459-64.

    ObjectiveTo assess the impact of calfactant (a modified natural bovine lung surfactant) in immunocompromised children with acute lung injury and to determine the number of patients required for a definitive clinical trial of calfactant in this population.DesignPost hoc analysis of data from a previous randomized, control trial.SettingTertiary care pediatric intensive care units.PatientsAll children, defined as immunocompromised, enrolled in a multicenter, masked, randomized, control trial of calfactant for acute lung injury conducted between July 2000 and July 2003.InterventionsPatients received either an intratracheal instillation of calfactant or an equal volume of air placebo in a protocolized manner.Measurements And Main ResultsEleven of 22 (50%) calfactant-treated patients died when compared with 18 of 30 (60%) placebo patients (absolute risk reduction 10.0%, 95% confidence interval [CI] -17.3, 37.3). Among the 23 patients with an initial oxygen index (OI) >/=13 and ConclusionsThese preliminary data suggest a potential benefit of calfactant in this high-risk population. A clinical trial powered to appropriately assess these findings seems warranted and feasible.

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