The SABRE Trial of Hypertonic Saline in Acute Bronchiolitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Sheffield Children's NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Sheffield
Information provided by (Responsible Party):
Sheffield Children's NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01469845
First received: November 9, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Sheffield Children's NHS Foundation Trust:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469845

Contacts
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

Locations
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         
Sponsors and Collaborators
Sheffield Children's NHS Foundation Trust
University of Sheffield
  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 April 15, 2014