Acute bronchiolitis Respiratory Acute bronchiolitis
Conditions
Interventions
Nebulised 3% hypertonic saline will be administered 6 hourly in the intervention group, in addition to standard supportive care, until the infant meets the pre-set criteria for discharge. A single use
driven by piped oxygen will be used to administer the hypertonic saline. The control arm will receive standard supportive care.
Total duration of follow-up will be 28 days from entry
Sponsors
Sheffield Children's NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion 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.
Exclusion criteria
Exclusion criteria: 1. Wheezy bronchitis or asthma ? children with an apparent viral respiratory infection and wheeze with no or occasional crepitations 2. Previous lower respiratory tract infections 3. Risk factors for severe disease (gestation < 32 weeks, immunodeficiency, neurological and cardiac conditions) 4. Participation in another study involving investigational medication 5. Subjects where the carer?s English is not fluent and translational services are not available 6. Requiring admission to high dependency or intensive care units at the time of recruitment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 27/10/2011: 1. Time to ?fit for discharge?, which will be judged to be when the infant is feeding adequately (taking more than 75% of usual intake) 2. Has been in air with a saturation of at least 92% for 6 hours, to reflect clinical practice. Previous primary outcome measures: 2. Has been in air with a saturation of 94% or greater for 12 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Actual time to discharge 2. Readmission within 28 days from randomisation 3. Health care utilisation, post-discharge and within 28 days from randomisation 4. Duration of respiratory symptoms post discharge and within 28 days from randomisation 5. Infant and parental quality of life using the Infant Toddler Quality of Life (ITQoL) questionnaire at 28 days following randomisation. | — |
Countries
United Kingdom
Outcome results
None listed