PEDIATRICS Vol. 104 No. 6 December 1999, p. e77

ELECTRONIC ARTICLE:
Prednisolone Treatment of Respiratory Syncytial Virus Infection: A Randomized Controlled Trial of 147 Infants

Received Jan 6, 1999; accepted Jun 24, 1999.

Susanne M. Bülow^*, Marta Nir, E. Levin^§, Birgitte Friis^§, Lise L. Thomsen, Jens Erik Nielsen^*, Jens-Christian Holm, Tina Møller^§, Mie E. Bonde-Hansen, and Hans Erik Nielsen^*

From the ^* Departments of Pediatrics, Gentofte Hopsital, Gentofte, Denmark; the  Department of Pediatrics, Glostrup Hopsital, Glostrup, Denmark; and the ^§ Department of Pediatrics, Roskilde Hospital, Roskilde, Denmark.

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.  Key words:  infants, respiratory syncytial virus, prednisolone, corticosteroids, treatment, randomized controlled trial.

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