The SABRE Trial of Hypertonic Saline in Acute Bronchiolitis | Completed
The SABRE Trial of Hypertonic Saline in Acute Bronchiolitis
Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Acute Bronchiolitis
Unfortunately contact details are not available for this trial.
Primary Contact Details
Recruitment Status
Primary Trial ID Number
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.
Research Details
    Sorry, this information is not available
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Type
Device : 3% hypertonic saline

Study Arm Groups : hypertonic saline and usual care, usual care (oxygen therapy)

Intervention Type
See Interventions above
Primary Outcome Measures
  • Time to 'fit for discharge'; 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
  • Actual time to discharge; This was measured from time to randomisation to the discharge time according to routine clinical guidelines.; Readmission; Within 28 days from randomisation; health care utilisation; post-discharge and within 28 days from randomisation; duration of respiratory symptoms; post discharge and within 28 days from randomisation; Infant and parental quality of life using the Infant Toddler Quality of Life (ITQoL) questionnaire; 28 days following randomisation.
Sorry, this information is not available
Result Reports
This is available on the website
Age Range
N/A - 12 Months
Who Can Participate
Sorry, this information is not available
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
  • 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
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Leeds General Infirmary
GSK Investigational Site
Site: 44
S10 2TH
GSK Investigational Site
L12 2AP
University Hospital of Wales
CF14 4XW
Rotherham NHS Foundation Trust, Rotherham Hospital
S60 2UD
Calderdale and Huddersfield NHS Foundation Trust
West Yorkshire
Pfizer Investigational Site
South Yorkshire
University Hospital of North Staffordshire
North Staffordshire
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific Title
Hypertonic Saline in Acute Bronchiolitis: Randomised Controlled Trial and Economic Evaluation
EudraCT Number
Not available for this trial
  • University of Sheffield
Other Study ID Numbers
Sheffield Children's NHS Foundation Trust
Key Dates

Recruitment Start Date

Oct 2011

Recruitment End Date

Dec 2014

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

09 Nov 2011

Last Updated

24 Mar 2015