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Mark L Everard 1, Daniel Hind 2,*, Kelechi Ugonna 3, Jennifer Freeman 4, Mike Bradburn 2, Simon Dixon 2, Chin Maguire 2, Hannah Cantrill 2, John Alexander 5, Warren Lenney 6, Paul McNamara 7, Heather Elphick 3, Philip AJ Chetcuti 8, Eduardo F Moya 9, Colin Powell 10, Jonathan P Garside 11, Lavleen Kumar Chadha 12, Matthew Kurian 12, Ravinderjit S Lehal 13, Peter I MacFarlane 14, Cindy L Cooper 2, Elizabeth Cross 2

1 School of Paediatrics and Child Health (SPACH), University of Western Australia, Perth, WA, Australia
2 School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK
3 Department of Respiratory Medicine, Sheffield Children’s NHS Foundation Trust, Sheffield, UK
4 Division of Epidemiology & Biostatistics, Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK
5 Children’s Centre, Hospital of North Staffordshire NHS Trust, Stoke-on-Trent, UK
6 Institute for Science & Technology in Medicine, Keele University, Stoke-on-Trent, UK
7 Department of Women’s and Children’s Health, University of Liverpool, Liverpool, UK
8 Children’s Respiratory Medicine, Leeds Teaching Hospitals NHS Trust, Leeds, UK
9 Department of Paediatrics, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK
10 Department of Child Health, University Hospital of Wales, Cardiff, UK
11 Children’s Outpatients, Calderdale and Huddersfield NHS Foundation Trust, Huddersfield, UK
12 Paediatrics, Doncaster and Bassetlaw Hospitals NHS Foundation Trust, Doncaster, UK
13 Paediatric Endocrinology, Oxford University Hospitals NHS Trust, Oxford, UK
14 Child Health, Rotherham NHS Foundation Trust, Rotherham, UK
* Corresponding author Email: d.hind@sheffield.ac.uk

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The full text of this issue is available as a PDF document from the Toolkit section on this page.

Abstract

BACKGROUND

Acute bronchiolitis is the most common cause of hospitalisation in infancy. Supportive care and oxygen are the cornerstones of management. A Cochrane review concluded that the use of nebulised 3% hypertonic saline (HS) may significantly reduce the duration of hospitalisation.

OBJECTIVE

To test the hypothesis that HS reduces the time to when infants were assessed as being fit for discharge, defined as in air with saturations of >â 92% for 6 hours, by 25%.

DESIGN

Parallel-group, pragmatic randomised controlled trial, cost-utility analysis and systematic review.

SETTING

Ten UK hospitals.

PARTICIPANTS

Infants with acute bronchiolitis requiring oxygen therapy were allocated within 4 hours of admission.

INTERVENTIONS

Supportive care with oxygen as required, minimal handling and fluid administration as appropriate to the severity of the disease, 3% nebulised HS every 屉 6 hours.

MAIN OUTCOME MEASURES

The trial primary outcome was time until the infant met objective discharge criteria. Secondary end points included time to discharge and adverse events. The costs analysed related to length of stay (LoS), readmissions, nebulised saline and other NHS resource use. Quality-adjusted life-years (QALYs) were estimated using an existing utility decrement derived for hospitalisation in children, together with the time spent in hospital in the trial.

DATA SOURCES

We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and other databases from inception or from 2010 onwards, searched ClinicalTrials.gov and other registries and hand-searched Chest, Paediatrics and Journal of Paediatrics to January 2015.

REVIEW METHODS

We included randomised/quasi-randomised trials which compared HS versus saline (屉 adjunct treatment) or no treatment. We used a fixed-effects model to combine mean differences for LoS and assessed statistical heterogeneity using the I (2) statistic.

RESULTS

The trial randomised 158 infants to HS (nâ =â 141 analysed) and 159 to standard care (nâ =â 149 analysed). There was no difference between the two arms in the time to being declared fit for discharge [median 76.6 vs. 75.9 hours, hazard ratio (HR) 0.95, 95% confidence interval (CI) 0.75 to 1.20] or to actual discharge (median 88.5 vs. 88.7 hours, HR 0.97, 95% CI 0.76 to 1.23). There was no difference in adverse events. One infant developed bradycardia with desaturation associated with HS. Mean hospital costs were £2595 and £2727 for the control and intervention groups, respectively (pâ =â 0.657). Incremental QALYs were 0.0000175 (pâ =â 0.757). An incremental cost-effectiveness ratio of £7.6M per QALY gained was not appreciably altered by sensitivity analyses. The systematic review comprised 15 trials (nâ =â 1922) including our own. HS reduced the mean LoS by -0.36 days (95% CI -0.50 to -0.22 days). High levels of heterogeneity (I (2)â =â 78%) indicate that the result should be treated cautiously.

CONCLUSIONS

In this trial, HS had no clinical benefit on LoS or readiness for discharge and was not a cost-effective treatment for acute bronchiolitis. Claims that HS achieves small reductions in LoS must be treated with scepticism.

FUTURE WORK

Well-powered randomised controlled trials of high-flow oxygen are needed.

STUDY REGISTRATION

This study is registered as NCT01469845 and CRD42014007569.

FUNDING DETAILS

This project was funded by the NIHR Health Technology Assessment (HTA) programme and will be published in full in Health Technology Assessment; Vol. 19, No. 66. See the HTA programme website for further project information.

Abstract

BACKGROUND

Acute bronchiolitis is the most common cause of hospitalisation in infancy. Supportive care and oxygen are the cornerstones of management. A Cochrane review concluded that the use of nebulised 3% hypertonic saline (HS) may significantly reduce the duration of hospitalisation.

OBJECTIVE

To test the hypothesis that HS reduces the time to when infants were assessed as being fit for discharge, defined as in air with saturations of >â 92% for 6 hours, by 25%.

DESIGN

Parallel-group, pragmatic randomised controlled trial, cost-utility analysis and systematic review.

SETTING

Ten UK hospitals.

PARTICIPANTS

Infants with acute bronchiolitis requiring oxygen therapy were allocated within 4 hours of admission.

INTERVENTIONS

Supportive care with oxygen as required, minimal handling and fluid administration as appropriate to the severity of the disease, 3% nebulised HS every 屉 6 hours.

MAIN OUTCOME MEASURES

The trial primary outcome was time until the infant met objective discharge criteria. Secondary end points included time to discharge and adverse events. The costs analysed related to length of stay (LoS), readmissions, nebulised saline and other NHS resource use. Quality-adjusted life-years (QALYs) were estimated using an existing utility decrement derived for hospitalisation in children, together with the time spent in hospital in the trial.

DATA SOURCES

We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and other databases from inception or from 2010 onwards, searched ClinicalTrials.gov and other registries and hand-searched Chest, Paediatrics and Journal of Paediatrics to January 2015.

REVIEW METHODS

We included randomised/quasi-randomised trials which compared HS versus saline (屉 adjunct treatment) or no treatment. We used a fixed-effects model to combine mean differences for LoS and assessed statistical heterogeneity using the I (2) statistic.

RESULTS

The trial randomised 158 infants to HS (nâ =â 141 analysed) and 159 to standard care (nâ =â 149 analysed). There was no difference between the two arms in the time to being declared fit for discharge [median 76.6 vs. 75.9 hours, hazard ratio (HR) 0.95, 95% confidence interval (CI) 0.75 to 1.20] or to actual discharge (median 88.5 vs. 88.7 hours, HR 0.97, 95% CI 0.76 to 1.23). There was no difference in adverse events. One infant developed bradycardia with desaturation associated with HS. Mean hospital costs were £2595 and £2727 for the control and intervention groups, respectively (pâ =â 0.657). Incremental QALYs were 0.0000175 (pâ =â 0.757). An incremental cost-effectiveness ratio of £7.6M per QALY gained was not appreciably altered by sensitivity analyses. The systematic review comprised 15 trials (nâ =â 1922) including our own. HS reduced the mean LoS by -0.36 days (95% CI -0.50 to -0.22 days). High levels of heterogeneity (I (2)â =â 78%) indicate that the result should be treated cautiously.

CONCLUSIONS

In this trial, HS had no clinical benefit on LoS or readiness for discharge and was not a cost-effective treatment for acute bronchiolitis. Claims that HS achieves small reductions in LoS must be treated with scepticism.

FUTURE WORK

Well-powered randomised controlled trials of high-flow oxygen are needed.

STUDY REGISTRATION

This study is registered as NCT01469845 and CRD42014007569.

FUNDING DETAILS

This project was funded by the NIHR Health Technology Assessment (HTA) programme and will be published in full in Health Technology Assessment; Vol. 19, No. 66. See the HTA programme website for further project information.

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