Objective: To examine ribavirin's effectiveness in otherwise well infants with respiratory syncytial virus (RSV)-associated respiratory failure.
Design: Prospective multicenter cohort study.
Setting: Pediatric critical care units affiliated with the Pediatric Critical Care Study Group; 38 centers from the United States and Canada participated.
Patients: Infants with RSV-associated respiratory failure undergoing mechanical ventilation.
Measurements and main results: Data collected included demographic information; dates of hospitalization, intensive care, and mechanical ventilation; all patient diagnoses; reason for tracheal intubation; dates of ribavirin use before and during mechanical ventilation; time in hours after intubation until ribavirin administration; Pediatric Risk of Mortality (PRISM) score; and outcome. A total of 439 patients received mechanical ventilation for RSV-associated respiratory failure; 223 were classified as previously well and met entry criteria. Ninety-one infants (41%) received ribavirin during mechanical ventilation. The PRISM scores during the initial 24 hours of intensive care and blood gas measurements before intubation were similar for patients who received ribavirin versus those who did not. Use of ribavirin during mechanical ventilation was associated with prolonged duration of mechanical ventilation (p < 0.01) in a multivariate model that controlled for patient age, gender, prematurity status, and use of ribavirin before intubation. Subgroup analysis of mechanical ventilation days for previously well patients was 5.0 +/- 4.2 in the no-ribavirin group versus 6.4 +/- 5.0 in the ribavirin group (p < 0.05) and for well premature infants was 6.3 +/- 4.9 in the no-ribavirin group versus 9.0 +/- 6.3 in the ribavirin group (p < 0.01). The mortality rates for the term and the premature groups were similar for treated and untreated patients.
Conclusions: Ribavirin administration during mechanical ventilation to previously well infants with RSV infection was not associated with reductions in either mortality rates or duration of mechanical ventilation. Additional clinical effectiveness studies are required to define specific groups in which the use of aerosolized ribavirin is indicated.