title: Aerosolized ribavirin in mechanically ventilated children with respiratory syncytial virus lower respiratory tract disease: a prospective, double-blind, randomized trial.
abstract: OBJECTIVE
  To study the effect of ribavirin aerosol therapy on the immediate clinical course of mechanically ventilated children with respiratory syncytial virus lower respiratory tract disease.
  
  
  METHODS
  Prospective, randomized, double-blind, placebo-controlled study.
  
  
  METHODS
  Pediatric intensive care unit (ICU) of a university teaching hospital.
  
  
  METHODS
  Forty-one children requiring mechanical ventilation for respiratory syncytial virus lower respiratory tract disease.
  
  
  METHODS
  Patients were stratified by the presence or absence of and underlying disease and then randomized to receive aerosolized ribavirin (20 mg/mL) or saline for 18 hrs/day for 5 days or until endotracheal extubation, whichever came first.
  
  
  RESULTS
  Dependent variables included the time course of the illness and the change in FIO2, ventilatory rate, PaO2/FIO2 ratio, and ventilatory-efficiency index of patients while they received aerosol therapy. Ribavirin- and placebo-treated patient groups were not significantly different in the number of ventilator days (6.4 +/- 6.9 vs. 8.2 +/- 10.1; p = .5), oxygen days (10.8 +/- 7.7 vs. 12.2 +/- 11.8; p = .9), ICU days (7.9 +/- 7.0 vs. 10.3 +/- 11.0; p = .7), or hospital days (12.9 +/- 9.7 vs. 16.2 +/- 14.0; p = .6) after the initiation of aerosol therapy. The change in FIO2, ventilatory rate, PaO2/FIO2 ratio, or ventilatory-efficiency index did not differ between the two groups. No ventilator malfunction was observed. There were six deaths caused by intractable hypoxemia in patients with underlying cardiopulmonary disease. Four of these deaths were in the placebo group and two in the ribavirin group (p = .5).
  
  
  CONCLUSIONS
  Ribavirin aerosol therapy can be safely administered to mechanically ventilated children with severe respiratory syncytial virus lower respiratory tract disease. However, this therapy does not appear to affect immediate clinical outcome in such patients.
authors.affiliation: Department of Pediatrics, Children's Hospital of Michigan, Wayne State University School of Medicine, Detroit.
authors.forename: K L
authors.initials: KL
authors.lastname: Meert
authors.forename: A P
authors.initials: AP
authors.lastname: Sarnaik
authors.forename: M J
authors.initials: MJ
authors.lastname: Gelmini
authors.forename: M W
authors.initials: MW
authors.lastname: Lieh-Lai
mesh_terms: D000336:Aerosols; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D015278:Intensive Care Units, Pediatric; D008297:Male; D011446:Prospective Studies; D012121:Respiration, Artificial; D018357:Respiratory Syncytial Virus Infections / Q000188:drug therapy* / Q000503:physiopathology; D012254:Ribavirin / Q000008:administration & dosage*
chemical_list: D000336:Aerosols; D012254:Ribavirin