Ignite Creation Date:
2024-05-06 @ 12:00 AM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01469845
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2011-11-09
Brief Title:
The SABRE Trial of Hypertonic Saline in Acute Bronchiolitis
Sponsor:
Sheffield Childrens NHS Foundation Trust
Organization:
Sheffield Childrens NHS Foundation Trust
Study Overview
Official Title:
Hypertonic Saline in Acute Bronchiolitis Randomised Controlled Trial and Economic Evaluation
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SABRE
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 childs 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 childrens 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
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 childs 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 childrens 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HTA099122 | OTHER_GRANT | NHS NIHR HTA | None |