SABRE: Hypertonic Saline in Acute Bronchiolitis: A Randomised Controlled Trial and Economic Evaluation

The Challenges

Acute bronchiolitis is the most common cause of babies being admitted to hospital. It can be caused by any of the common cold viruses, although most cases are caused by the respiratory syncytial virus. If the virus gets into the lungs, it can cause difficulties in breathing on top of the head cold. The worst-affected babies require oxygen and help with feeding until they clear the virus themselves. Many treatments have been tried, but in all cases they were shown to be ineffective when properly tested. Most recently, it has been suggested that inhaling a mist of 3% hypertonic saline (salt water) from a nebuliser would reduce the length of time that babies spend in hospital.unable to demonstrate any benefit from its use. The treatment itself caused side effects in a few babies,such as excessive coughing and a fall in blood oxygen levels.

The Research

To test this suggestion, we undertook a trial and recruited 317 babies from 10 hospitals. All had bronchiolitis that was severe enough at admission for the babies to require treatment with oxygen. All received what is considered to be the best standard of care. Half of the babies were also treated with nebulised 3% saline every 6 hours.

The Results

We found that the nebulised treatment had no effect on the time it took for babies to be ready for discharge and we were unable to demonstrate any benefit from its use. The treatment itself caused side effects in a few babies, such as excessive coughing and a fall in blood oxygen levels.

When we combined the results of our trial with those of other trials in a systematic review and meta-analysis, we showed the results of the existing Cochrane review had overstated treatment effects. Early, small trials had shown large treatment effects, whereas later, large trials, in whose findings we should place more confidence showed no treatment effect.

For this reason, we believe that hypertonic saline is an ineffective and unnecessary treatment for infants with acute bronchiolitis

The Impact

Not yet known, as there are publications still in progress.

Publications

Everard ML, Hind D, Ugonna K, Freeman J, Bradburn M, Dixon S, et al. Saline in Acute Bronchiolitis RCT and Economic evaluation: hypertonic saline in acute bronchiolitis - randomised controlled trial and systematic review. Health Technol Assess. 2015;19(66):1–130.

Everard ML, Hind D, Ugonna K, Freeman J, Bradburn M, Cooper CL, et al. SABRE: a multicentre randomised control trial of nebulised hypertonic saline in infants hospitalised with acute bronchiolitis. Thorax. 2014;69(12):1105–1112.

Maguire C, Cantrill H, Hind D, Bradburn M, Everard ML. Hypertonic saline (HS) for acute bronchiolitis: Systematic review and meta-analysis. BMC Pulm Med. 2015;15(1):148.

Project Staff


Name Site Telephone number E-mail
Kelechi Ugonna
Chief Investigator
Sheffield Children's Hospital +44 (0)114 2717000

kelechi.ugonna@sch.nhs.uk

Danny Hind
Assistant Director, CTRU
ScHARR +44 (0)114 2220707 d.hind@sheffield.ac.uk
Kirsty Sprange 
Trial Manager(s)
ScHARR +44 (0)114 2222969

k.sprange@sheffield.ac.uk

Hannah Cantrill
Research Assistant 
ScHARR +44 (0)114 2224347 h.cantrill@sheffield.ac.uk
Kylie Cross
Trial Support Officer
ScHARR +44 (0)114 2226385 kylie.cross@sheffield.ac.uk
Amanda Loban
Data Manager
ScHARR +44 (0)114 2222995 a.loban@sheffield.ac.uk
Chris Ellis
Data Manager
ScHARR +44 (0)114 2220678 c.j.ellis@sheffield.ac.uk
Simon Dixon
Health Economist
ScHARR +44 (0)114 2220724 s.dixon@sheffield.ac.uk
Jenny Freeman
Statistician
ScHARR +44 (0)114 2220695 j.v.freeman@sheffield.ac.uk

Participating Centres

Centre Name Principal Investigator Research Nurse(s)
Alder Hey Children's Hospital, Liverpool (closed to recruitment, December 2013) Dr Paul McNamara Gail Wallace
Hannah Leyland
Tim Henderson
Bradford Royal Infirmary (closed to recruitment, March 2013) Dr Eduardo Moya Louise Akeroyd
Kelly Young
University Hospital of Wales, Cardiff (closed to recruitment, March 2013) Dr Colin Powell Caroline Amphlett
Pauline Jones
Doncaster Royal Infirmary (closed to recruitment, March 2013) Dr Matthew Kurian Sarah Johns
Janet Queen
Calderdale Royal Hospital, Halifax (closed to recruitment, March 2013) Dr Jonathan Garside Rachel Swingler
Leeds General Infirmary (closed to recruitment, March 2013) Dr Phillip Chetcuti Rebecca Mottram
Marjorie Allen
Nicola Balatoni
John Radcliffe Hospital, Oxford
Horton Hospital, Oxford (closed to recruitment, March 2013)
Dr Ravi Lehal Jennie McKenna
Louise Willis
Sheffield Children's Hospital (closed to recruitment, December 2013) Dr Heather Elphick Sarah Shortland
Janet Queen

City General Hospital, Stoke (closed to recruitment, December 2013)

Dr John Alexander Marie Phipps
Ruth Jones
Jo Tomlinson
Rotherham General Hospital (closed to recruitment, March 2012) Dr Peter MacFarlane

Sheffield School of Health and Related Research
University of Sheffield
30 Regent Court
Sheffield
S1 4DA

Tel: +44 (0)114 2225454
Fax: +44(0)114 2724095