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NCT Number: NCT01469845

The SABRE Trial of Hypertonic Saline in Acute Bronchiolitis

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.

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Key information

Conditions

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alder Hey Children's NHS Foundation Trust Hospital, Liverpool, Merseyside, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3% Hypertonic Saline

Device

4 ml dose to be administered every 6 hours

Other names: mucoclear 3%

Primary outcomes

  1. 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.

    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 outcomes

  1. Actual time to discharge

    Time frame: This was measured from time to randomisation to the discharge time according to routine clinical guidelines.

    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.

  2. Readmission

    Time frame: Within 28 days from randomisation

    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.

  3. health care utilisation

    Time frame: post-discharge and within 28 days from randomisation

    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

  4. duration of respiratory symptoms

    Time frame: post discharge and within 28 days from randomisation

    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

  5. Infant and parental quality of life using the Infant Toddler Quality of Life (ITQoL) questionnaire

    Time frame: 28 days following randomisation.

    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

Sponsors and collaborators

Lead sponsor

Sheffield Children's NHS Foundation Trust

Other

Collaborators

  • University of Sheffield

Registry information

Official study title

Hypertonic Saline in Acute Bronchiolitis: Randomised Controlled Trial and Economic Evaluation

Acronym: SABRE

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Nov 10, 2011
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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