Abstract | OBJECTIVE: DESIGN: Post hoc analysis of data from a previous randomized, control trial. SETTING: Tertiary care pediatric intensive care units. PATIENTS: All 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. INTERVENTIONS: Patients received either an intratracheal instillation of calfactant or an equal volume of air placebo in a protocolized manner. MEASUREMENTS AND MAIN RESULTS: Eleven 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 </=37, 44% (4 of 9) of calfactant-treated patients died in comparison with 71% (10 of 14) of placebo (absolute risk reduction 27.0%, 95% CI -13.2, 67.2). Only 33% (3 of 9) of calfactant patients died before intensive care discharge in comparison with 71% (10 of 14) of placebo (absolute risk reduction 38.1%, 95% CI -0.7, 76.9). Calfactant therapy was associated with improved oxygenation in these 23 patients. Using an OI entry criterion of (13 </= OI </= 37), stratifying on the presence of hematopoietic stem cell transplantation, and accepting the 27% difference in mortality observed in this analysis, 63 patients would be required in each arm of a randomized, control trial to demonstrate a significant effect of calfactant on mortality in this patient population assuming a two-sided alpha of 0.05 and a power of 0.85. CONCLUSIONS: These 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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Authors | Robert F Tamburro, Neal J Thomas, Steven Pon, Brian R Jacobs, Joseph V Dicarlo, Barry P Markovitz, Larry S Jefferson, Douglas F Willson, Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network |
Journal | Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies
(Pediatr Crit Care Med)
Vol. 9
Issue 5
Pg. 459-64
(Sep 2008)
ISSN: 1529-7535 [Print] United States |
PMID | 18679142
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Biological Products
- Pulmonary Surfactants
- calfactant
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Topics |
- Acute Lung Injury
(drug therapy, physiopathology)
- Adolescent
- Biological Products
(administration & dosage, therapeutic use)
- Child
- Clinical Trials as Topic
- Female
- Humans
- Immunocompromised Host
- Male
- Pulmonary Surfactants
(administration & dosage, therapeutic use)
- Treatment Outcome
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