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

NCT06069336 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-05-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Szpital im. Św. Jadwigi Śląskiej

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Weeks
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06069336 on ClinicalTrials.gov