ABSTRACT. Objective. To evaluate the effect of systemic prednisolone as an adjunct to conventional treatment with 2-agonist, respiratory support, and fluid replacement in hospitalized infants <24 months of age with respiratory syncytial virus (RSV) infection.Methods. The study was randomized, double-blind, and placebo-controlled. During the winter of 1995-1996, 147 infants <2 years of age, hospitalized with RSV infection, were allocated to treatment with either systemic prednisolone mixture 2 mg/kg daily or placebo for 5 days.Main Outcome Measures. The acute effect variables were duration of stay in hospital, use of medicine, and supportive measures while in hospital. At follow-up 1 month after discharge, the acute effect variables were duration of illness, start in day care center, morbidity, and use of medicine. At follow-up 1 year after discharge, the acute effect variables were morbidity, use of medicine, and skin prick tests with allergens.Results. Prednisolone treatment had no effect on any of the outcome measures.Conclusions. Our randomized prospective study in infants hospitalized with acute RSV infection showed no effect of systemic prednisolone treatment either in the acute state of RSV infection, nor in the follow-up 1 month and 1 year after admission to hospital. We find our results in agreement with the largest studies reported earlier; therefore, corticosteroid, whether by the systemic route or by inhalation, should not be prescribed to infants with RSV infection. Pediatrics 1999;104(6). URL: http://www.pediatrics.org/cgi/content/full/104/6/e77; infants, respiratory syncytial virus, prednisolone, corticosteroids, treatment, randomized controlled trial.ABBREVIATIONS. RSV, respiratory syncytial virus; IV, intravenous; CPAP, continuous positive airway pressure. P revious studies have shown that a majority of infants are infected with respiratory syncytial virus (RSV) during their first or second year of life.1 However, only a minority of these children are admitted to hospital.
2Because of many clinical and presumed pathophysiological similarities between RSV infection and asthma, corticosteroid has been used widely for treatment of RSV infections. [3][4][5] Of the reports of randomized, controlled studies of systemic corticosteroid treatment of RSV infection in infants, 7 have shown conflicting results.6 -12 However, these studies are not directly comparable because of the differences of diagnostic criteria, exclusion criteria, and measures of effect.This study investigates the short-term and longterm effects of systemic corticosteroid treatment in a large, unselected group of infants hospitalized with RSV infection.
METHODSThe 3 participating pediatric departments serve the County of Copenhagen and 1 neighboring county with a joint population of ϳ34 000 infants Ͻ2 years of age. A total of 147 hospitalized infants were included prospectively between November 1995 and April 1996.
Inclusion CriteriaPatients Ͻ2 years of age hospitalized with respiratory infection and a positive RSV test were included i...