The SABRE Trial of Hypertonic Saline in Acute Bronchiolitis

This study has been completed.
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: March 24, 2015
Last verified: March 2015
  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

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

Primary Outcome Measures:
  • Time to 'fit for discharge' [ Time Frame: 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. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Actual time to discharge [ Time Frame: This was measured from time to randomisation to the discharge time according to routine clinical guidelines. ] [ Designated as safety issue: No ]
    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.

  • Readmission [ Time Frame: Within 28 days from randomisation ] [ Designated as safety issue: Yes ]
    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.

  • health care utilisation [ Time Frame: post-discharge and within 28 days from randomisation ] [ Designated as safety issue: Yes ]
    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

  • duration of respiratory symptoms [ Time Frame: post discharge and within 28 days from randomisation ] [ Designated as safety issue: Yes ]
    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

  • 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 ]
    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


Enrollment: 300
Study Start Date: October 2011
Study Completion Date: January 2014
Primary Completion Date: December 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01469845

Locations
United Kingdom
Alder Hey Children's NHS Foundation Trust Hospital
Liverpool, Merseyside, United Kingdom, L12 2AP
University Hospital of North Staffordshire
Stoke, North Staffordshire, United Kingdom, ST4 6QG
University Hospital of Wales
Cardiff, South Wales, United Kingdom, CF14 4XW
Doncaster & Bassetlaw Hospitals NHS Foundation Trust
Doncaster, South Yorkshire, United Kingdom, DN2 5LT
Rotherham NHS Foundation Trust
Rotherham, South Yorkshire, United Kingdom, S60 2UD
Sheffield Children's NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom, S10 2TH
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, West Yorkshire, United Kingdom, BD9 6RJ
Calderdale and Huddersfield NHS Foundation Trust
Halifax, West Yorkshire, United Kingdom
Leeds Teaching Hospital NHS Trust
Leeds, West Yorkshire, United Kingdom, LS1 3EX
Sponsors and Collaborators
Sheffield Children's NHS Foundation Trust
University of Sheffield
  More Information

Additional Information:
No publications provided by Sheffield Children's NHS Foundation Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: March 24, 2015
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
Bronchial Diseases
Bronchitis
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 27, 2015