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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
4 ml dose to be administered every 6 hours
Alder Hey Children's NHS Foundation Trust Hospital
Liverpool, Merseyside, United Kingdom
University Hospital of North Staffordshire
Stoke, North Staffordshire, United Kingdom
University Hospital of Wales
Cardiff, South Wales, United Kingdom
Doncaster & Bassetlaw Hospitals NHS Foundation Trust
Doncaster, South Yorkshire, United Kingdom
Rotherham NHS Foundation Trust
Rotherham, South Yorkshire, United Kingdom
Sheffield Children's NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, West Yorkshire, United Kingdom
Calderdale and Huddersfield NHS Foundation Trust
Halifax, West Yorkshire, United Kingdom
Leeds Teaching Hospital NHS Trust
Leeds, West Yorkshire, United Kingdom
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.
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.
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.
Time frame: This was measured from time to randomisation to the discharge time according to routine clinical guidelines.
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.
Time frame: Within 28 days from randomisation
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
Time frame: post-discharge and within 28 days from randomisation
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
Time frame: post discharge and within 28 days from randomisation
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
Time frame: 28 days following randomisation.
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