Normal saline for children with bronchiolitis: study protocol for a randomised controlled non-inferiority trial

Area of Science:

• Pediatrics
• Respiratory Medicine
• Clinical Trials

Background:

• Bronchiolitis is a leading cause of childhood hospital admissions.
• Current guidelines suggest normal saline (NS) for airway mucus clearance, but evidence is lacking.
• Paediatric departments commonly use nebulised NS, primarily as inpatient care.

Purpose of the Study:

• To directly test the efficacy of saline treatments in infants hospitalized with bronchiolitis.
• To compare nebulised NS, nasal irrigation with NS, and no saline therapy.
• To determine the impact of saline therapy on hospitalisation duration and respiratory support needs.

Main Methods:

• A multicentre, open-label, randomised controlled non-inferiority trial.
• 300 infants (0-12 months) admitted with bronchiolitis.
• Randomisation to nebulised NS, nasal irrigation with NS, or no saline therapy; primary outcome is duration of hospitalisation.

Main Results:

• The study is ongoing; results are not yet available.
• The primary outcome is duration of hospitalisation, analysed by intention-to-treat.
• Secondary outcomes include respiratory support needs and fluid supplementation requirements.

Conclusions:

• Findings will inform clinical practice and potentially global guidelines for bronchiolitis supportive care.
• If effective, saline therapy could be implemented more widely.
• Comparing nasal irrigation to nebulisation may reveal options for reduced healthcare provider workload and earlier home-based treatment.