|
Health Condition(s) or Problem
|
Acute Bronchiolitis
|
|
Lay 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.
(from ClinicalTrials.gov)
|
|
Who can enter the trial
|
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
|
|
Who cannot enter the trial
|
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
|
|
What will happen
|
Device; 3% hypertonic saline; 4 ml dose to be administered every 6 hours; hypertonic saline and usual care; usual care (oxygen therapy); mucoclear 3%
|
|
Primary aim
|
Time to 'fit for discharge', which will be judged to be when the infant is feeding adequately [taking >75% of usual intake] and has been in air with a saturation of at least 92% for 6 hours, to reflect clinical practice.
|
|
Secondary Aim
|
Actual time to discharge; No; Readmission; Within 28 days from randomisation; Yes; health care utilisation; post-discharge and within 28 days from randomisation; Yes; duration of respiratory symptoms; post discharge and within 28 days from randomisation; Yes; Infant and parental quality of life using the Infant Toddler Quality of Life (ITQoL) questionnaire; 28 days following randomisation.; No
|
|
Participant Information Sheet
|
Sorry, not currently available
|
|
Website
|
http://www.shef.ac.uk/scharr/sabre; http://www.hta.ac.uk
|
|
Recruitment Status
|
Recruiting
|
|
Nation
|
England, Wales
|
|
Location
|
Liverpool, Stoke-on-Trent, Cardiff, Doncaster, Rotherham, Sheffield, Bradford, Halifax, Leeds
|