The SABRE Trial of Hypertonic Saline in Acute Bronchiolitis

Study Overview
=================
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.

Official Title
-----------------
Hypertonic Saline in Acute Bronchiolitis: Randomised Controlled Trial and Economic Evaluation

Conditions
-----------------
Acute Bronchiolitis

Intervention / Treatment
-----------------
* Device: 3% hypertonic saline


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Maximum Age: 12 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: hypertonic saline and usual care<br> | Device: 3% hypertonic saline<br>* 4 ml dose to be administered every 6 hours<br>* Other names: mucoclear 3%;|
| Active Comparator: usual care (oxygen therapy)<br> | Device: 3% hypertonic saline<br>* 4 ml dose to be administered every 6 hours<br>* Other names: mucoclear 3%;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hospital admissions, acute bronchiolitis, under one year old, requiring oxygen therapy