Abstract | RATIONALE: OBJECTIVE: DESIGN AND SETTING: Masked, randomized, placebo-controlled trial in 24 children's hospitals in six different countries. PATIENTS AND METHODS: 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 A total of 110 subjects were enrolled, with consent withdrawn from one whose data are unavailable.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:
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Authors | Douglas F Willson, Neal J Thomas, Robert Tamburro, Edward Truemper, Jonathon Truwit, Mark Conaway, Christine Traul, Edmund E Egan, Pediatric Acute Lung and Sepsis Investigators 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. 14
Issue 7
Pg. 657-65
(Sep 2013)
ISSN: 1529-7535 [Print] United States |
PMID | 23846250
(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, mortality)
- Biological Products
(therapeutic use)
- Blood Gas Analysis
- Child
- Child, Preschool
- Female
- Humans
- Male
- Pulmonary Surfactants
(therapeutic use)
- Respiration, Artificial
- Respiratory Distress Syndrome, Newborn
(drug therapy, mortality)
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