Effect of 3 and 6%hypertonic saline in viral bronchiolitis: A RCT

Background: Bronchiolitis is a common disorder in young children, often resulting in hospitalisation. Beside a possible effect of 3% NaCl (HS) no evidence based therapy is available.Previous studies show a reduction in hospital stay after nebulisation with 3%HS. Objectives : This study investigated the efficacy of nebulised 3% and 6% HS compared to NS in children hospitalised with viral bronchiolitis. We hypothesised that nebulisation with HS would dose dependently reduce the length of hospital stay. Methods: In this multicentre randomised double-blind controlled trial, 292 children, median age 3.4month, hospitalised with acute viral bronchiolitis were randomised to receive either nebulised 3%, 6% HS or NS during the whole period of hospital stay. Salbutamol was added to counteract possible bronchial constriction. Primary endpoint was length of hospital stay, secondary outcomes need for supplemental oxygen and tube feeding. Children younger than 2 years with clinical diagnosis of viral bronchiolitis, not responding to a single Salbutamol-inhalation were included. Results : 247 children completed the study. Patient characteristics and the reasons of exclusion didn9t differ significantly. Median length of hospital stay 69h(IQR 57) for 3%, 70h(IQR 69) for 6%, 53h(IQR 52) for NS (p=0.29) and secondary outcomes didn9t differ between the groups. Adverse effects were similar in the three groups. Conclusion: Nebulisation with HS (3 and 6%) compared to NS, although safe, did not reduce length of hospital stay, duration of supplemental oxygen or tube feeding in children hospitalised with mild to severe viral bronchiolitis. This is in contrast with previous international studies. Further research has to clear up this question.