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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014758-14-GB

Enrollment

224

Registered

2010-03-17

Start date

2010-05-13

Completion date

Unknown

Last updated

2020-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Viral bronchiolitis (in infants aged under 1yr old) MedDRA version: 12-1 Level: LLT Classification code 10038718 Term: (Respiratory syncytial virus) bronchiolitis

Interventions

Product Name: Hypertonic saline (3%) Pharmaceutical Form: Nebuliser solution INN or Proposed INN: 3% (hypertonic) saline (NaCl) Concentration unit: % percent Concentration type: equal Concentration nu

Eligibility

Sex/Gender

All

Inclusion criteria

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: 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.

Design outcomes

Primary

Measure	Time frame
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. 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	—

Measure

Time frame

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. 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

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026