The SABRE Trial of Hypertonic Saline in Acute Bronchiolitis (SABRE)

March 24, 2015 updated by: Sheffield Children's NHS Foundation Trust

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

Acute bronchiolitis is a common, distressing illness affecting children. A virus infects the lungs, and then the airways become blocked, leading to difficulties with breathing. It is the most common reason why children are admitted to hospital, with 1-3% of all children admitted to hospital during their first winter, creating enormous strains on NHS services. The majority of those admitted with the condition are under six months of age and the associated stress for parents is considerable. After forty years of research the best treatment we have is supportive care and oxygen.

Recent research suggests that salt water, sprayed as a mist so that the children can breathe it in ('nebulised 3% hypertonic saline') might help children with acute bronchiolitis. Scientists think that the salt water changes the mucus which blocks the airways so that it can be cleared more easily. Three small research studies all suggested that a child's time in hospital could be reduced by a quarter by using this treatment. If this was true, it would be good for children, their families and the children's wards trying to cope with the large numbers admitted with bronchiolitis every year.

To decide whether this treatment should be used throughout the NHS, we need to run a randomised controlled trial of hypertonic saline in a large number of children. The trial will tell us if adding saline to usual care reduces distress in both children and parents, as well as whether it reduces the length of time they stay in hospital. We will then know if the treatment is the best thing for children with bronchiolitis and whether it provides the NHS with good value for money.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L12 2AP
        • Alder Hey Children's NHS Foundation Trust Hospital
    • North Staffordshire
      • Stoke, North Staffordshire, United Kingdom, ST4 6QG
        • University Hospital of North Staffordshire
    • South Wales
      • Cardiff, South Wales, United Kingdom, CF14 4XW
        • University Hospital of Wales
    • South Yorkshire
      • Doncaster, South Yorkshire, United Kingdom, DN2 5LT
        • Doncaster & Bassetlaw Hospitals NHS Foundation Trust
      • Rotherham, South Yorkshire, United Kingdom, S60 2UD
        • Rotherham NHS Foundation Trust
      • Sheffield, South Yorkshire, United Kingdom, S10 2TH
        • Sheffield Children's NHS Foundation Trust
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD9 6RJ
        • Bradford Teaching Hospitals NHS Foundation Trust
      • Halifax, West Yorkshire, United Kingdom
        • Calderdale and Huddersfield NHS Foundation Trust
      • Leeds, West Yorkshire, United Kingdom, LS1 3EX
        • Leeds Teaching Hospital NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previously healthy infants under 1 year of age
  • Admitted to hospital with a clinical diagnosis of acute bronchiolitis, following the UK definition of an infant with an apparent viral respiratory tract infection associated with airways obstruction manifest by hyperinflation, tachypnoea and subcostal recession with widespread crepitations on auscultation
  • Requiring supplemental oxygen therapy on admission

Exclusion Criteria:

  • Wheezy bronchitis or asthma - children with an apparent viral respiratory infection and wheeze with no or occasional crepitations
  • Previous lower respiratory tract infections
  • Risk factors for severe disease [gestation <32 weeks, immunodeficiency, neurological and cardiac conditions, chronic lung disease]
  • Subjects where the carer's English is not fluent and translational services are not available
  • Requiring admission to high dependency or intensive care units at the time of recruitment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: hypertonic saline and usual care
Device: 3% hypertonic saline
4 ml dose to be administered every 6 hours
Other Names:
  • mucoclear 3%
Active Comparator: usual care (oxygen therapy)
Device: 3% hypertonic saline
4 ml dose to be administered every 6 hours
Other Names:
  • mucoclear 3%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to 'fit for discharge'
Time Frame: This was judged to be when the infant was feeding adequately [taking >75% of usual intake] and was in air with a saturation of at least 92% for 6 hours, to reflect clinical practice.
The primary objective was an analysis, to show if the addition of 3% hypertonic saline to usual care results in significant [25%] reduction in the duration of hospitalisation of infants admitted with acute bronchiolitis. This outcome was measured at 6 hourly intervals, with the first evaluation at time of randomisation.
This was judged to be when the infant was feeding adequately [taking >75% of usual intake] and was in air with a saturation of at least 92% for 6 hours, to reflect clinical practice.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Actual time to discharge
Time Frame: This was measured from time to randomisation to the discharge time according to routine clinical guidelines.
The secondary objectives were assessments of the economic impact of such an intervention on both the NHS and parents, as well as quality of life and other health related outcomes assessed 28 days after entry to the study.
This was measured from time to randomisation to the discharge time according to routine clinical guidelines.
Readmission
Time Frame: Within 28 days from randomisation
The secondary objectives were assessments of the economic impact of such an intervention on both the NHS and parents, as well as quality of life and other health related outcomes assessed 28 days after entry to the study.
Within 28 days from randomisation
health care utilisation
Time Frame: post-discharge and within 28 days from randomisation
The secondary objectives were assessments of the economic impact of such an intervention on both the NHS and parents, as well as quality of life and other health related outcomes assessed 28 days after entry to the study
post-discharge and within 28 days from randomisation
duration of respiratory symptoms
Time Frame: post discharge and within 28 days from randomisation
The secondary objectives were assessments of the economic impact of such an intervention on both the NHS and parents, as well as quality of life and other health related outcomes assessed 28 days after entry to the study
post discharge and within 28 days from randomisation
Infant and parental quality of life using the Infant Toddler Quality of Life (ITQoL) questionnaire
Time Frame: 28 days following randomisation.
The secondary objectives were assessments of the economic impact of such an intervention on both the NHS and parents, as well as quality of life and other health related outcomes assessed 28 days after entry to the study
28 days following randomisation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Children's NHS Foundation Trust

Collaborators

University of Sheffield

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

November 9, 2011

First Submitted That Met QC Criteria

November 9, 2011

First Posted (Estimate)

November 10, 2011

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCH/1/016
  • HTA09/91/22 (Other Grant/Funding Number: NHS NIHR HTA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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