AEROSOLIZED RIBAVIRIN IN MECHANICALLY VENTILATED CHILDREN WITH RESPIRATORY SYNCYTIAL VIRUS LOWER RESPIRATORY-TRACT DISEASE - A PROSPECTIVE,DOUBLE-BLIND, RANDOMIZED TRIAL

Objective: To study the effect of ribavirin aerosol therapy on the imm ediate clinical course of mechanically ventilated children with respir atory syncytial virus lower respiratory tract disease. Design: Prospec tive, randomized, double-blind, placebo-controlled study. Setting: Ped iatric intensive care unit (IGU) of a university teaching hospital. Pa tients: Forty-one children requiring mechanical ventilation for respir atory syncytial virus lower respiratory tract disease. Interventions: 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. Measurements and Main Results: Dependent varia bles included the time course of the illness and the change in FIO2, v entilatory rate, Pao(2)/FIO2 ratio, and ventilatory-efficiency index o f 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 hospitaldays (12.9 +/- 9.7 vs. 16.2 +/- 14.0; p = .6)after the initiation of aerosol therapy. The change in FIO2, v entilatory rate, Pao(2)/FIO2 ratio, or ventilatory-efficiency index di d not differ between the two groups. No ventilator malfunction was obs erved. There were six deaths caused by intractable hypoxemia in patien ts with underlying cardiopulmonary disease. Four of these deaths were in the placebo group and two in the ribavirin group (p = .5). Conclusi ons: Ribavirin aerosol therapy can be safely administered to mechanica lly ventilated children with severe respiratory syncytial virus lower respiratory tract disease. However, this therapy does not appear to af fect immediate clinical outcome in such patients.