Does nebulised hypertonic (3%) saline reduce the duration of hospital admission in infants with bronchiolitis? - Nebulised hypertonic (3%) saline in the treatment of bronchiolitis

Phase 1

• Conditions: Viral bronchiolitis (in infants aged under 1yr old); MedDRA version: 12-1Level: LLTClassification code 10038718Term: (Respiratory syncytial virus) bronchiolitis

• Registration Number: EUCTR2009-014758-14-GB
• Lead Sponsor: West Middlesex University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-17
• Study Completion: 2010-12-31
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

Inclusion criteria - all infants under the age of 12 months with a clinical diagnosis of bronchiolitis

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria - infants who are transferred out of West Middlesex Hospital whilst enrolled in the trial and those that have a change of diagnosis during their admission. For example, a number of infants with bronchiolitis end up receiving intravenous antibiotics for probably super-added bacterial lower respiratory tract infection. In these cases, the antibiotics may be a significant confounding factor to any findings and hence infants will no longer be eligible for inclusion, as commencing treatment with antibiotics suggests that viral bronchiolitis is not the primary diagnosis.

However, data will be analysed regardless, as the quality of any evidence is superior if there is an intention to treat analysis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether using nebulised 3% saline (salty water) is effective in reducing the severity and duration of symptoms in bronchiolitis, which is a viral respiratory infection affecting children under the age of 12 months.<br><br>The outcomes that will be measured are a) duration of hospital stay and b) duration of supplemental oxygen requirement.;Secondary Objective: None;Primary end point(s): Duration of hospital stay<br>