Hypertonic Saline in Acute Bronchiolitis

Not Applicable

Completed

• Conditions: Acute bronchiolitis; Respiratory

• Registration Number: ISRCTN31128055
• Lead Sponsor: Sheffield Children's NHS Foundation Trust (UK)

Brief Summary

2014 results in http://www.ncbi.nlm.nih.gov/pubmed/25389139

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-23
• Study Completion: 2012-04-30
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measures as of 27/10/2011:<br> 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)<br> 2. Has been in air with a saturation of at least 92% for 6 hours, to reflect clinical practice.<br><br> Previous primary outcome measures:<br> 2. Has been in air with a saturation of 94% or greater for 12 hours<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Actual time to discharge<br> 2. Readmission within 28 days from randomisation<br> 3. Health care utilisation, post-discharge and within 28 days from randomisation<br> 4. Duration of respiratory symptoms post discharge and within 28 days from randomisation<br> 5. Infant and parental quality of life using the Infant Toddler Quality of Life (ITQoL) questionnaire at 28 days following randomisation.<br>