NCT01469845

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

2.2 years

First QC Date

November 9, 2011

Last Update Submit

March 24, 2015

Conditions

Acute Bronchiolitis

Keywords

hospital admissionsacute bronchiolitisunder one year oldrequiring oxygen therapy

Outcome Measures

Primary Outcomes (1)

  • Time to 'fit for discharge'

    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.

    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 Outcomes (5)

  • 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.

Study Arms (2)

hypertonic saline and usual care

ACTIVE COMPARATOR
Device: 3% hypertonic saline

usual care (oxygen therapy)

ACTIVE COMPARATOR
Device: 3% hypertonic saline

Interventions

3% hypertonic salineDEVICE

4 ml dose to be administered every 6 hours

Also known as: mucoclear 3%
hypertonic saline and usual careusual care (oxygen therapy)

Eligibility Criteria

AgeUp to 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Alder Hey Children's NHS Foundation Trust Hospital

Liverpool, Merseyside, L12 2AP, United Kingdom

Location

University Hospital of North Staffordshire

Stoke, North Staffordshire, ST4 6QG, United Kingdom

Location

University Hospital of Wales

Cardiff, South Wales, CF14 4XW, United Kingdom

Location

Doncaster & Bassetlaw Hospitals NHS Foundation Trust

Doncaster, South Yorkshire, DN2 5LT, United Kingdom

Location

Rotherham NHS Foundation Trust

Rotherham, South Yorkshire, S60 2UD, United Kingdom

Location

Sheffield Children's NHS Foundation Trust

Sheffield, South Yorkshire, S10 2TH, United Kingdom

Location

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, West Yorkshire, BD9 6RJ, United Kingdom

Location

Calderdale and Huddersfield NHS Foundation Trust

Halifax, West Yorkshire, United Kingdom

Location

Leeds Teaching Hospital NHS Trust

Leeds, West Yorkshire, LS1 3EX, United Kingdom

Location

Related Publications (2)

  • Everard ML, Hind D, Ugonna K, Freeman J, Bradburn M, Dixon S, Maguire C, Cantrill H, Alexander J, Lenney W, McNamara P, Elphick H, Chetcuti PA, Moya EF, Powell C, Garside JP, Chadha LK, Kurian M, Lehal RS, MacFarlane PI, Cooper CL, Cross E. Saline in acute bronchiolitis RCT and economic evaluation: hypertonic saline in acute bronchiolitis - randomised controlled trial and systematic review. Health Technol Assess. 2015 Aug;19(66):1-130. doi: 10.3310/hta19660.

    PMID: 26295732DERIVED

  • Everard ML, Hind D, Ugonna K, Freeman J, Bradburn M, Cooper CL, Cross E, Maguire C, Cantrill H, Alexander J, McNamara PS; SABRE Study Team. SABRE: a multicentre randomised control trial of nebulised hypertonic saline in infants hospitalised with acute bronchiolitis. Thorax. 2014 Dec;69(12):1105-12. doi: 10.1136/thoraxjnl-2014-205953.

    PMID: 25389139DERIVED

Related Links

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2011

First Posted

November 10, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

March 25, 2015

Record last verified: 2015-03

Locations

GB(9)