Abstract | CONTEXT: OBJECTIVE: To determine if endotracheal instillation of calfactant in infants, children, and adolescents with ALI would shorten the course of respiratory failure. DESIGN, SETTING, AND PATIENTS: A multicenter, randomized, blinded trial of calfactant compared with placebo in 153 infants, children, and adolescents with respiratory failure from ALI conducted from July 2000 to July 2003. Twenty-one tertiary care pediatric intensive care units participated. Entry criteria included age 1 week to 21 years, enrollment within 48 hours of endotracheal intubation, radiological evidence of bilateral lung disease, and an oxygenation index higher than 7. Premature infants and children with preexisting lung, cardiac, or central nervous system disease were excluded. INTERVENTION: Treatment with intratracheal instillation of 2 doses of 80 mL/m2 calfactant or an equal volume of air placebo administered 12 hours apart. MAIN OUTCOME MEASURES: RESULTS: The calfactant group experienced an acute mean (SD) decrease in oxygenation index from 20 (12.9) to 13.9 (9.6) after 12 hours compared with the placebo group's decrease from 20.5 (14.7) to 15.1 (9.0) (P = .01). Mortality was significantly greater in the placebo group compared with the calfactant group (27/75 vs 15/77; odds ratio, 2.32; 95% confidence interval, 1.15-4.85), although ventilator-free days were not different. More patients in the placebo group did not respond to conventional mechanical ventilation. There were no differences in long-term complications. CONCLUSIONS:
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Authors | Douglas F Willson, Neal J Thomas, Barry P Markovitz, Loren A Bauman, Joseph V DiCarlo, Steven Pon, Brian R Jacobs, Larry S Jefferson, Mark R Conaway, Edward A Egan, Pediatric Acute Lung Injury and Sepsis Investigators |
Journal | JAMA
(JAMA)
Vol. 293
Issue 4
Pg. 470-6
(Jan 26 2005)
ISSN: 1538-3598 [Electronic] United States |
PMID | 15671432
(Publication Type: Clinical Trial, 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 |
- Adolescent
- Adult
- Biological Products
(administration & dosage, therapeutic use)
- Child
- Child, Preschool
- Female
- Humans
- Infant
- Infant, Newborn
- Intubation, Intratracheal
- Male
- Pulmonary Surfactants
(administration & dosage, therapeutic use)
- Respiratory Distress Syndrome
(drug therapy)
- Respiratory Distress Syndrome, Newborn
(drug therapy)
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