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

Health Conditions
  • Acute Bronchiolitis
Completed
Recruitment Status
NCT01469845
Primary Trial ID Number
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.
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.
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
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Publications
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Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
N/A to 12 Months
Participant Type
Sorry, this information is not available
Trial Sample Size
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
  • 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
Interventions
Device; 3% hypertonic saline; 4 ml dose to be administered every 6 hours; [hypertonic saline and usual care, usual care (oxygen therapy)]
Design Details
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Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Results Reporting
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Acronym
SABRE
Scientific Title
Hypertonic Saline in Acute Bronchiolitis: Randomised Controlled Trial and Economic Evaluation
Secondary Trial Identifying Number
HTA09/91/22
Website
http://www.shef.ac.uk/scharr/sabre; http://www.hta.ac.uk
Study Funded By
Sheffield Children's NHS Foundation Trust
Funder Type
Sorry, this information is not available
Study Sponsored By
Sheffield Children's NHS Foundation Trust
Study Also Sponsored By
University of Sheffield
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

09 Nov 2011

Last Updated

24 Mar 2015

Date Record Refreshed on UKCTG

31 Jul 2015