Abstract
Background and aims: At present only symptomatic treatment is available for acute viral bronchiolitis, none of these are evidence-based. Recent trials show a reduction in hospital stay after inhalation of 3% hypertonic saline solution. This randomised double-blind, placebo-controlled interventional multicenter trial, performed at 12 Dutch hospitals, compares nebulization with hypertonic saline, either a 3% or 6%, with 0.9% isotonic saline. The primary end point is the time to discharge, aiming to achieve a 25% reduction in hospital stay.
Methods: Children younger than two years with clinical diagnosis of viral bronchiolitis, not responding to a single inhalation with Salbutamol may be included after informed parental consent. Trial medication will be nebulized three times daily until discharge criteria are met. Calculated power of 80% requires totally 156 patients.
Results: The analysis was performed on the data of 160 patients, all included in the seasons 2009-january 2011. Patient characteristics and the number of exclusions didn't differ significantly. The duration of hospital stay, need for tube feeding and supplemental oxygen shows no significant difference, but there's a trend that 3% seems tob e more effective than the other 2 concentrations.
Conclusions: Preliminary analysis showed no significant reduction in hospital stay but a trend that 3% hypertonic saline is the most effective regarding duration of hospital stay, need for supplemental oxygen and tube feeding. The use of 6% hypertonic saline seems safe but has no additional benefit even compared with 0,9%. More research will be necessary to clear up this trend.
- © 2011 ERS