SABRE: a multicentre randomised control trial of nebulised hypertonic saline in infants hospitalised with acute bronchiolitis.
OBJECTIVE
Acute bronchiolitis is the commonest cause for hospitalisation in infancy. Supportive care remains the cornerstone of current management and no other therapy has been shown to influence the course of the disease. It has been suggested that adding nebulised hypertonic saline to usual care may shorten the duration of hospitalisation. To determine whether hypertonic saline does have beneficial effects we undertook an open, multi-centre parallel-group, pragmatic RCT in ten UK hospitals.


METHODS
Infants admitted to hospital with a clinical diagnosis of acute bronchiolitis and requiring oxygen therapy were randomised to receive usual care alone or nebulised 3% hypertonic saline (HS) administered 6-hourly. Randomisation was within 4 h of admission. The primary outcome was time to being assessed as 'fit' for discharge with secondary outcomes including time to discharge, incidence of adverse events together with follow up to 28 days assessing patient centred health related outcomes.


RESULTS
A total of 317 infants were recruited to the study. 158 infants were randomised to HS (141 analysed) and 159 to standard care (149 analysed). There was no difference between the two arms in time to being declared fit for discharge (hazard ratio: 0-95, 95% CI: 0.75-1.20) nor to actual discharge (hazard ratio: 0.97, 95% CI: 0.76-1.23). There was no difference in adverse events. One infant in the HS group developed bradycardia with desaturation.


CONCLUSIONS
This study does not support the use of nebulised HS in the treatment of acute bronchiolitis over usual care with minimal handlings.


BACKGROUND
NCT01469845.
University of Western Australia, Perth, Western Australia, Australia.
Mark L
ML
Everard
University of Sheffield, Sheffield, UK.
Daniel
D
Hind
Sheffield Children's NHS Foundation Trust, Sheffield, UK.
Kelechi
K
Ugonna
University of Leeds, Leeds, UK.
Jennifer
J
Freeman
University of Sheffield, Sheffield, UK.
Mike
M
Bradburn
University of Sheffield, Sheffield, UK.
Cindy L
CL
Cooper
University of Sheffield, Sheffield, UK.
Elizabeth
E
Cross
University of Sheffield, Sheffield, UK.
Chin
C
Maguire
University of Sheffield, Sheffield, UK.
Hannah
H
Cantrill
University Hospital of North Staffordshire NHS Trust, Stoke-on-Trent, UK.
John
J
Alexander
University of Liverpool, Liverpool, UK.
Paul S
PS
McNamara
D000208:Acute Disease; D000280:Administration, Inhalation; D001990:Bronchiolitis, Viral / Q000628:therapy*; D005260:Female; D006760:Hospitalization; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D015278:Intensive Care Units, Pediatric; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D009330:Nebulizers and Vaporizers; D010102:Oxygen Inhalation Therapy; D012462:Saline Solution, Hypertonic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D012462:Saline Solution, Hypertonic
Nebuliser therapy; Paediatric Lung Disaese; Viral infection