February 2000
GENTOFTE, Denmark - A recent study conducted at three pediatric departments here showed that prednisolone treatment had no effect on outcome measures in infants hospitalized with respiratory syncytial virus (RSV) infection. No effect was seen at one-month or one-year follow-up.
The randomized, double-blind, placebo-controlled trial conducted during the winter of 1995-1996 included 147 infants younger than 2 years who were hospitalized with RSV infection. The patients were allocated to treatment with oral prednisolone hydrate administered once-daily at 5 mg/kg, or placebo. Infants who had an intravenous (IV) line received 40 mg/mL of methylprednisolone or saline once daily.
During the five-day study period, the hospitals followed their normal treatment for RSV infection, including b2-agonist inhalation, respiratory support, fluid replacement and antibiotic treatment, when indicated. There were no significant treatment differences between the two groups. If an infant was discharged before five days, the parents administered the randomized drug for the remainder of the study period.
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The parents recorded duration of illness, morbidity and use of medications until the one-month clinical follow-up. Researchers contacted the parents again 10 to 11 months after initial admission and asked them to record morbidity and the use of medicine for six weeks prior to the infants' one-year follow-up.
The researchers found no significant differences after the first month between the prednisolone group and the infants who received placebo. The time from entry into the study until when parents felt their child to be completely healthy was similar among the two groups (11.4 days in the prednisolone group and 11.5 days in the placebo group). The time until the infants were able to return to day care was also similar (11.9 days in the prednisolone group and 11.3 days for the placebo group). The number of infants treated with b2-agonists or inhaled corticosteroids after discharge, frequency of night coughing and re-admissions due to respiratory tract infections were also similar between the two groups.
Researchers also found no significant differences in morbidity between the prednisolone group and placebo group during the 12 months following discharge from the hospital. There were no differences in frequency of night coughing or readmission due to respiratory tract infection. Sixty percent of the infants were diagnosed with asthmatic bronchiolitis during the year following initial hospital admission for RSV infection. Otitis media was diagnosed in 29 infants after discharge. Skin prick testing was performed on 119 infants. Test results were positive in three of 58 infants from the prednisolone group and in only one of the 61 patients from the placebo group.
Bronchiolitis, asthmatic bronchiolitis and wheezing in infants have been treated for many years with corticosteroids. This recent study demonstrated that prednisolone had no effect when used as an adjunct to conventional treatment with b2-agonist, respiratory support and fluid replacement in the treatment of RSV infection in this population. Therefore, the researchers concluded that corticosteroids should not be used for treatment of RSV infection in infants younger than 2 years.
For more information:
- Bulow SM, Nir M, Levine E. et al. Prednisolone treatment of respiratory syncytial virus infection: a randomized controlled trial of 147 infants. Pediatrics. 1999;104(6):e77.
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