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| ID | Type | Description | Link |
|---|---|---|---|
| HTA09/91/22 | Other Grant/Funding Number | NHS NIHR HTA |
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| Name | Class |
|---|---|
| University of Sheffield | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hypertonic saline and usual care | Active Comparator |
| |
| usual care (oxygen therapy) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3% hypertonic saline | Device | 4 ml dose to be administered every 6 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alder Hey Children's NHS Foundation Trust Hospital | Liverpool | Merseyside | L12 2AP | United Kingdom | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26295732 | Derived | 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. | |
| 25389139 |
| Label | URL |
|---|---|
| Study specific website | View source |
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| 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 |
| 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 |
| 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 |
| 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. |
| University Hospital of North Staffordshire |
| Stoke |
| North Staffordshire |
| ST4 6QG |
| United Kingdom |
| University Hospital of Wales | Cardiff | South Wales | CF14 4XW | United Kingdom |
| Doncaster & Bassetlaw Hospitals NHS Foundation Trust | Doncaster | South Yorkshire | DN2 5LT | United Kingdom |
| Rotherham NHS Foundation Trust | Rotherham | South Yorkshire | S60 2UD | United Kingdom |
| Sheffield Children's NHS Foundation Trust | Sheffield | South Yorkshire | S10 2TH | United Kingdom |
| Bradford Teaching Hospitals NHS Foundation Trust | Bradford | West Yorkshire | BD9 6RJ | United Kingdom |
| Calderdale and Huddersfield NHS Foundation Trust | Halifax | West Yorkshire | United Kingdom |
| Leeds Teaching Hospital NHS Trust | Leeds | West Yorkshire | LS1 3EX | United Kingdom |
| Derived |
| 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. |