Evidence map›Paper›PMID 25389139›Full record

Trial reportThorax2014

SABRE: a multicentre randomised control trial of nebulised hypertonic saline in infants hospitalised with acute bronchiolitis.

Mark L Everard, Daniel Hind, Kelechi Ugonna, Jennifer Freeman, Mike Bradburn, Cindy L Cooper, Elizabeth Cross, Chin Maguire, Hannah Cantrill, John Alexander and 2 more

2 registry-linked trialsOpen access · hybridAbstract readMulticenter StudyRandomized Controlled TrialPragmatic Clinical Trial
In one paragraph

Trial report in Thorax, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 28 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 6 pooled it
11.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01469845 phase3completednot on this map

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

TypeinterventionalSponsorSheffield Children's NHS Foundation TrustRan2011 to 2014Enrolled300ConditionsAcute BronchiolitisArms3% hypertonic saline
NCT02760719 phase2terminatednot on this mapstarted 2015, after this paper: background citation

The Effectiveness of Nebulized 3% Hypertonic Saline With Salbutamol in Acute Bronchiolitis in Hospitalised Children- a Randomized Clinical Trial

TypeinterventionalSponsorUniversity Medical Centre LjubljanaRan2015 to 2019Enrolled100ConditionsBronchiolitisArmsnebulized 3% hypertonic solution
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 6 syntheses or guidelines pooled it, 111 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Nebulised hypertonic saline solution for acute bronchiolitis in infants.The Cochrane database of systematic reviews · 2017
    Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Trial
  10. Article
  11. Article
  12. Article
  13. Nebulised hypertonic saline solution for acute bronchiolitis in infants.The Cochrane database of systematic reviews · 2023
    Review
  14. Review
  15. Article
  16. Review
  17. Article
  18. Efficacy of 3% hypertonic saline in bronchiolitis: A meta-analysis.Experimental and therapeutic medicine · 2019
    Article
  19. Article
  20. Viral bronchiolitis.Lancet (London, England) · 2017
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 6 institutions in 2 countries.

Mark L EverardUniversity of Western Australia, Perth, Western Australia, Australia.
Daniel HindUniversity of Sheffield, Sheffield, UK.
Kelechi UgonnaSheffield Children's NHS Foundation Trust, Sheffield, UK.
Jennifer FreemanUniversity of Leeds, Leeds, UK.
Mike BradburnUniversity of Sheffield, Sheffield, UK.
Cindy L CooperUniversity of Sheffield, Sheffield, UK.
Elizabeth CrossUniversity of Sheffield, Sheffield, UK.
Chin MaguireUniversity of Sheffield, Sheffield, UK.
Hannah CantrillUniversity of Sheffield, Sheffield, UK.
John AlexanderUniversity Hospital of North Staffordshire NHS Trust, Stoke-on-Trent, UK.
Paul S McNamaraUniversity of Liverpool, Liverpool, UK.
SABRE Study Team
University of Sheffield · GBSheffield Children's NHS Foundation Trust · GBUniversity Hospitals of North Midlands NHS Trust · GBUniversity of Leeds · GBUniversity of Liverpool · GBUniversity of Western Australia · AU

Funding

Department of Health 09/91/22
6 · The paper itself

Abstract

aimAcute 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.

methodsInfants 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.

resultsA 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.

conclusionThis study does not support the use of nebulised HS in the treatment of acute bronchiolitis over usual care with minimal handlings. CLINICALTRIALSGOV REGISTRATION NUMBER: NCT01469845.

Indexed as

Acute DiseaseAdministration, InhalationBronchiolitis, ViralFemaleHospitalizationHumansInfantInfant, NewbornIntensive Care Units, PediatricLength of StayMaleNebulizers and VaporizersOxygen Inhalation TherapySaline Solution, HypertonicTreatment OutcomeSaline Solution, HypertonicNebuliser therapyPaediatric Lung DisaeseViral infection

Identifiers

PMID25389139
PMCPMC4251206
OpenAlexW2162742958

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.