NCT06069336

Nebulised 3% Hypertonic Saline Versus 0.9% Saline for Treating Patients Hospitalized With Acute Bronchiolitis

Nebulised 3% Hypertonic Saline Versus 0.9% Saline for Treating Patients Hospitalized With Acute Bronchiolitis: Protocol of a Randomized, Double-blind, Multicentre Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Szpital im. Św. Jadwigi Śląskiej · Academic / Other
• Sex: All
• Age: 5 Weeks – 24 Months
• Healthy volunteers: Not accepted

Summary

Bronchiolitis is an acute viral infection of the lower respiratory tract. It is most commonly caused by respiratory syncytial virus (RSV). Only supportive therapy, including suctioning nasal secretions, water-electrolyte balance maintenance, and oxygen supplementation when needed, is recommended. The inhalation of 3% hypertonic saline is not recommended in bronchiolitis management. However, a recently published meta-analysis revealed that the inhalation of hypertonic saline can reduce the risk of hospitalisation for outpatients with bronchiolitis, while resulting in a shorter length of hospital stay and reduced severity of respiratory distress for inpatients, although the evidence is of low certainty. The aim of the study is to assess the efficacy of nebulised hypertonic saline for the treatment of children hospitalised with bronchiolitis.

Conditions

• Bronchiolitis

Interventions

Type	Name	Description
DRUG	Hypertonic saline	Nebulised 3% hypertonic saline (NEBU-dose hypertonic). Nebulisation will be performed by trained study nurses or by parents under the supervision of a nurse
DRUG	Normal saline	0,9% normal saline (NEBU-dose isotonic). Nebulisation will be performed by trained study nurses or by parents under the supervision of a nurse

Timeline

• Start date: 2023-11-01
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2023-10-05
• Last updated: 2025-05-18

Locations

3 sites across 1 country: Poland