Clinical trial NCT01469845: The SABRE Trial of Hypertonic Saline in Acute Bronchiolitis
Official title: Hypertonic Saline in Acute Bronchiolitis: Randomised Controlled Trial and Economic Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Bronchiolitis
Keywords: hospital admissions
acute bronchiolitis
under one year old
requiring oxygen therapy
Lead sponsor: Sheffield Children's NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Sheffield
First posted: 2011-11-10
Enrollment: 300
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Time to 'fit for discharge'
timeFrame: 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 outcomes:
measure: Actual time to discharge
timeFrame: This was measured from time to randomisation to the discharge time according to routine clinical guidelines.
measure: Readmission
timeFrame: Within 28 days from randomisation
measure: health care utilisation
timeFrame: post-discharge and within 28 days from randomisation
measure: duration of respiratory symptoms
timeFrame: post discharge and within 28 days from randomisation
measure: Infant and parental quality of life using the Infant Toddler Quality of Life (ITQoL) questionnaire
timeFrame: 28 days following randomisation.
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Alder Hey Children's NHS Foundation Trust Hospital
state: Merseyside
city: Stoke
country: United Kingdom
facility: University Hospital of North Staffordshire
state: North Staffordshire
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
state: South Wales
city: Doncaster
country: United Kingdom
facility: Doncaster & Bassetlaw Hospitals NHS Foundation Trust
state: South Yorkshire
city: Rotherham
country: United Kingdom
facility: Rotherham NHS Foundation Trust
state: South Yorkshire
city: Sheffield
country: United Kingdom
facility: Sheffield Children's NHS Foundation Trust
state: South Yorkshire
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals NHS Foundation Trust
state: West Yorkshire
city: Halifax
country: United Kingdom
facility: Calderdale and Huddersfield NHS Foundation Trust
state: West Yorkshire
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospital NHS Trust
state: West Yorkshire
Study officials:
References:
citation: Everard ML, Hind D, Ugonna K, Freeman J, Bradburn M, Dixon S, Maguire C, Cantrill H, Alexander J, Lenney W, McNamara P, Elphick H, Chetcuti PA, Moya EF, Powell C, Garside JP, Chadha LK, Kurian M, Lehal RS, MacFarlane PI, Cooper CL, Cross E. Saline in acute bronchiolitis RCT and economic evaluation: hypertonic saline in acute bronchiolitis - randomised controlled trial and systematic review. Health Technol Assess. 2015 Aug;19(66):1-130. doi: 10.3310/hta19660.
citation: Everard ML, Hind D, Ugonna K, Freeman J, Bradburn M, Cooper CL, Cross E, Maguire C, Cantrill H, Alexander J, McNamara PS; SABRE Study Team. SABRE: a multicentre randomised control trial of nebulised hypertonic saline in infants hospitalised with acute bronchiolitis. Thorax. 2014 Dec;69(12):1105-12. doi: 10.1136/thoraxjnl-2014-205953.