RT Journal Article
SR Electronic
T1 Late-breaking abstract: Hypertonic saline in acute bronchiolitis: Randomised controlled trial (RCT) and economic evaluation (the SABRE study)
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P3451
VO 44
IS Suppl 58
A1 Mark L Everard
A1 Daniel Hind
A1 Jennifer V Freeman
A1 Mike Bradburn
YR 2014
UL http://erj.ersjournals.com/content/44/Suppl_58/P3451.abstract
AB DESIGN: Parallel-group, pragmatic RCT in 10 UK hospitals. METHODS: Infants with acute bronchiolitis - lower respiratory tract infection resulting in airflow obstruction, increase work of breathing and wide spread crepitations on auscultation - requiring oxygen therapy, were eligible. Randomisation, within 4 hrs of admission, was to standard supportive care with oxygen as required, minimal handling and fluid administration as appropriate to the severity of the disease, +/- 6-hourly 3% nebulized hypertonic saline (HS). The hypothesis was that the intervention would result in a 25% reduction in the primary outcome expressed as a hazard ratio (HR), the time to when infants were assessed as being ‘fit for discharge', defined as, in air with saturations of >92% for 6 hrs. Analysts were blind to allocation. RESULTS: The trial recruited to target when 158 infants were randomized to HS (141 analysed) and 159 to standard care (149 analysed). There was no difference between the two arms in the time to being declared fit for discharge (HR: 0.95, 95% CI: 0.75-1.20) nor to actual discharge (HR: 0.97, 95% CI: 0.76-1.23). There was no difference in adverse events. One infant developed bradycardia with desaturation associated with HS. CONCLUSIONS: This study does not support the use of nebulized HS in the treatment of acute bronchiolitis. REGISTRATION: NCT01469845 FUNDING: National Institute for Health Research.