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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01469845
Other study ID # SCH/1/016
Secondary ID HTA09/91/22
Status Completed
Phase Phase 3
First received November 9, 2011
Last updated March 24, 2015
Start date October 2011
Est. completion date January 2014

Study information

Verified date March 2015
Source Sheffield Children's NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Department of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date January 2014
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 12 Months
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
3% hypertonic saline
4 ml dose to be administered every 6 hours

Locations

Country Name City State
United Kingdom Bradford Teaching Hospitals NHS Foundation Trust Bradford West Yorkshire
United Kingdom University Hospital of Wales Cardiff South Wales
United Kingdom Doncaster & Bassetlaw Hospitals NHS Foundation Trust Doncaster South Yorkshire
United Kingdom Calderdale and Huddersfield NHS Foundation Trust Halifax West Yorkshire
United Kingdom Leeds Teaching Hospital NHS Trust Leeds West Yorkshire
United Kingdom Alder Hey Children's NHS Foundation Trust Hospital Liverpool Merseyside
United Kingdom Rotherham NHS Foundation Trust Rotherham South Yorkshire
United Kingdom Sheffield Children's NHS Foundation Trust Sheffield South Yorkshire
United Kingdom University Hospital of North Staffordshire Stoke North Staffordshire

Sponsors (2)

Lead Sponsor Collaborator
Sheffield Children's NHS Foundation Trust University of Sheffield

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. No
Secondary Actual time to discharge 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. This was measured from time to randomisation to the discharge time according to routine clinical guidelines. No
Secondary Readmission 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. Within 28 days from randomisation Yes
Secondary health care utilisation 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 post-discharge and within 28 days from randomisation Yes
Secondary duration of respiratory symptoms 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 post discharge and within 28 days from randomisation Yes
Secondary Infant and parental quality of life using the Infant Toddler Quality of Life (ITQoL) questionnaire 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 28 days following randomisation. No
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