Acute Bronchiolitis
Conditions
Keywords
hospital admissions, acute bronchiolitis, under one year old, requiring oxygen therapy
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.
Interventions
DEVICE3% hypertonic saline
4 ml dose to be administered every 6 hours
Sponsors
University of Sheffield
Sheffield Children's NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to 'fit for discharge' | 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
| Measure | Time frame | Description |
|---|---|---|
| Actual time to discharge | 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. |
| Readmission | 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. |
| health care utilisation | 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 |
| duration of respiratory symptoms | 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 |
| Infant and parental quality of life using the Infant Toddler Quality of Life (ITQoL) questionnaire | 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 |
Countries
United Kingdom
Outcome results
None listed