Ribavirin in ventilated respiratory syncytial virus bronchiolitis - A randomized, placebo-controlled trial

We undertook a prospective, double-blind, placebo-controlled trial to resol ve the question of the clinical effectiveness of ribavirin in previously we ll infants who require ventilation for respiratory distress secondary to re spiratory syncytial virus (RSV) bronchiolitis. Aerosol ribavirin or NaCl 0. 9% was administered within 24 h of initiation of ventilation, 18 h/d, for a maximum of 7 d or until extubation. From March 1994 to March 1997, 42 chil dren were randomized and 41 patients were retained for analysis. Baseline c haracteristics of each group-ribavirin and placebo (20:21)-were not signifi cantly different with respect to age (62.5 +/- 35.9 versus 62.7 +/- 30.9 d) , sex, weight, and length of ventilation pre-aerosol. "Intent to treat" out come analysis found no significant differences in the length of the followi ng: ventilation (102.16 +/- 65.26 versus 126.28 +/- 78.72 h; p = 0.29), aer osol therapy, stay in the intensive care unit, total oxygen therapy, and ho spitalization. The aerosols were well tolerated and no deaths occurred. Thi s trial demonstrates the lack of effectiveness of aerosolized ribavirin in reducing the length of ventilation and course of illness in infants with no underlying illness ventilated for respiratory distress secondary to RSV br onchiolitis.