The SABRE Trial of Hypertonic Saline in Acute Bronchiolitis

Acute Bronchiolitis Clinical Trial

— SABRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01469845
• Other study ID #: SCH/1/016
• Secondary ID: HTA09/91/22
• Status: Completed
• Phase: Phase 3
• First received: November 9, 2011
• Last updated: March 24, 2015
• Start date: October 2011
• Est. completion date: January 2014

Study information

• Verified date: March 2015
• Source: Sheffield Children's NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Bronchiolitis
• Bronchiolitis

Intervention

Device:
• 3% hypertonic saline
4 ml dose to be administered every 6 hours

Locations

Country	Name	City	State
United Kingdom	Bradford Teaching Hospitals NHS Foundation Trust	Bradford	West Yorkshire
United Kingdom	University Hospital of Wales	Cardiff	South Wales
United Kingdom	Doncaster & Bassetlaw Hospitals NHS Foundation Trust	Doncaster	South Yorkshire
United Kingdom	Calderdale and Huddersfield NHS Foundation Trust	Halifax	West Yorkshire
United Kingdom	Leeds Teaching Hospital NHS Trust	Leeds	West Yorkshire
United Kingdom	Alder Hey Children's NHS Foundation Trust Hospital	Liverpool	Merseyside
United Kingdom	Rotherham NHS Foundation Trust	Rotherham	South Yorkshire
United Kingdom	Sheffield Children's NHS Foundation Trust	Sheffield	South Yorkshire
United Kingdom	University Hospital of North Staffordshire	Stoke	North Staffordshire

Sponsors (2)

Lead Sponsor	Collaborator
Sheffield Children's NHS Foundation Trust	University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to 'fit for discharge'	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.	No
Secondary	Actual time to discharge	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.	No
Secondary	Readmission	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	Yes
Secondary	health care utilisation	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	Yes
Secondary	duration of respiratory symptoms	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	Yes
Secondary	Infant and parental quality of life using the Infant Toddler Quality of Life (ITQoL) questionnaire	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.	No

External Links

•   Government funding body
•   Study specific website