Status:
COMPLETED
The SABRE Trial of Hypertonic Saline in Acute Bronchiolitis
Lead Sponsor:
Sheffield Children's NHS Foundation Trust
Collaborating Sponsors:
University of Sheffield
Conditions:
Acute Bronchiolitis
Eligibility:
All Genders
Up to 12 years
Phase:
PHASE3
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01469845
Start Date
October 1 2011
End Date
January 1 2014
Last Update
March 25 2015
Active Locations (9)
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1
Alder Hey Children's NHS Foundation Trust Hospital
Liverpool, Merseyside, United Kingdom, L12 2AP
2
University Hospital of North Staffordshire
Stoke, North Staffordshire, United Kingdom, ST4 6QG
3
University Hospital of Wales
Cardiff, South Wales, United Kingdom, CF14 4XW
4
Doncaster & Bassetlaw Hospitals NHS Foundation Trust
Doncaster, South Yorkshire, United Kingdom, DN2 5LT