The SABRE Trial of Hypertonic Saline in Acute Bronchiolitis
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Bronchiolitis |
Device: 3% hypertonic saline |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Hypertonic Saline in Acute Bronchiolitis: Randomised Controlled Trial and Economic Evaluation |
- Time to 'fit for discharge', which will be judged to be when the infant is feeding adequately [taking >75% of usual intake] and has been in air with a saturation of at least 92% for 6 hours, to reflect clinical practice. [ Designated as safety issue: No ]
- Actual time to discharge [ Designated as safety issue: No ]
- Readmission [ Time Frame: Within 28 days from randomisation ] [ Designated as safety issue: Yes ]
- health care utilisation [ Time Frame: post-discharge and within 28 days from randomisation ] [ Designated as safety issue: Yes ]
- duration of respiratory symptoms [ Time Frame: post discharge and within 28 days from randomisation ] [ Designated as safety issue: Yes ]
- Infant and parental quality of life using the Infant Toddler Quality of Life (ITQoL) questionnaire [ Time Frame: 28 days following randomisation. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: hypertonic saline and usual care |
Device: 3% hypertonic saline
4 ml dose to be administered every 6 hours
Other Name: mucoclear 3%
|
| Active Comparator: usual care (oxygen therapy) |
Device: 3% hypertonic saline
4 ml dose to be administered every 6 hours
Other Name: mucoclear 3%
|
Eligibility| Ages Eligible for Study: | up to 12 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Mark L Everard, DM | 0044 114 271 7400 | m.l.everard@sheffield.ac.uk |
| Contact: Liz A Cross, MA | 0044 114 222 0762 | e.a.cross@sheffield.ac.uk |
| United Kingdom | |
| Alder Hey Children's NHS Foundation Trust Hospital | Recruiting |
| Liverpool, Merseyside, United Kingdom, L12 2AP | |
| Contact: Paul McNamara mcnamp@liv.ac.uk | |
| Contact: Ian Sinha iansinha@liv.ac.uk | |
| Principal Investigator: Paul McNamara | |
| University Hospital of North Staffordshire | Recruiting |
| Stoke, North Staffordshire, United Kingdom, ST4 6QG | |
| Contact: John Alexander john.alexander@uhns.nhs.uk | |
| Principal Investigator: John Alexander | |
| University Hospital of Wales | Recruiting |
| Cardiff, South Wales, United Kingdom, CF14 4XW | |
| Contact: Colin Powell powellc7@cardiff.ac.uk | |
| Principal Investigator: Colin Powell | |
| Doncaster & Bassetlaw Hospitals NHS Foundation Trust | Recruiting |
| Doncaster, South Yorkshire, United Kingdom, DN2 5LT | |
| Contact: Mathew Kurian mathew.kurian@dbh.nhs.uk | |
| Principal Investigator: Mathew Kurian | |
| Rotherham NHS Foundation Trust | Recruiting |
| Rotherham, South Yorkshire, United Kingdom, S60 2UD | |
| Contact: Peter Macfarlane peter.macfarlane@rothgen.nhs.uk | |
| Principal Investigator: Peter Macfarlane | |
| Sheffield Children's NHS Foundation Trust | Recruiting |
| Sheffield, South Yorkshire, United Kingdom, S10 2TH | |
| Contact: Heather Elphick heather.elphick@sch.nhs.uk | |
| Principal Investigator: Heather Elphick | |
| Bradford Teaching Hospitals NHS Foundation Trust | Recruiting |
| Bradford, West Yorkshire, United Kingdom, BD9 6RJ | |
| Contact: Eduardo Moya Eduardo.Moya@bthft.nhs.uk | |
| Principal Investigator: Eduardo Moya | |
| Calderdale and Huddersfield NHS Foundation Trust | Recruiting |
| Halifax, West Yorkshire, United Kingdom | |
| Contact: Garside Jonathan jonathan.garside@cht.nhs.uk | |
| Principal Investigator: Jonathan Garside | |
| Leeds Teaching Hospital NHS Trust | Recruiting |
| Leeds, West Yorkshire, United Kingdom, LS1 3EX | |
| Contact: Philip Chetcuti philip.chetcuti@leedsth.nhs.uk | |
| Principal Investigator: Philip Chetcuti | |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sheffield Children's NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT01469845 History of Changes |
| Other Study ID Numbers: | SCH/1/016, HTA09/91/22 |
| Study First Received: | November 9, 2011 |
| Last Updated: | November 9, 2011 |
| Health Authority: | United Kingdom: Department of Health |
Keywords provided by Sheffield Children's NHS Foundation Trust:
|
hospital admissions acute bronchiolitis under one year old requiring oxygen therapy |
Additional relevant MeSH terms:
|
Bronchiolitis Bronchitis Bronchial Diseases Respiratory Tract Diseases |
Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 16, 2013