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Nebulised 3% Hypertonic Saline in Infants With Acute Bronchiolitis

Evaluating the Efficacy of Nebulised 3% Hypertonic Saline for Acute Bronchiolitis in Infants: A Study at Can Tho Children's Hospital, 2022-2024

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06558461
Enrollment
140
Registered
2024-08-16
Start date
2022-06-01
Completion date
2024-05-28
Last updated
2024-08-16

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

Conditions

Acute Bronchiolitis

Keywords

Bronchiolitis, 3% hypertonic saline

Brief summary

This study aims to determine the efficacy of nebulising 3% hypertonic saline in improving clinical symptoms and reducing the length of hospital stay in infants with acute bronchiolitis.

Detailed description

Bronchiolitis is the most prevalent disease in infants, especially children younger than two years old. Clinical manifestations vary from mild to severe, even life-threatening respiratory failure. Airway oedema and mucus plugging are the principal pathological features in infants with acute bronchiolitis. Nebulising 3% hypertonic saline solution may reduce these pathological changes, but the evidence remains equivocal.

Interventions

4ml nebulized three times daily

OTHERStandard care

Standard care

Sponsors

Can Tho University of Medicine and Pharmacy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

A randomized controlled open-label parallel-arm clinical trial, with allocation 1:1, was conducted to investigate whether nebulizing 3% hypertonic saline will improve clinical symptoms and reduce the length of hospital stay in bronchiolitis compared with the control group.

Eligibility

Sex/Gender
ALL
Age
1 Months to 24 Months
Healthy volunteers
No

Inclusion criteria

* Pediatric patients diagnosed with acute bronchiolitis from 1 to 24 months old at Can Tho Children's Hospital.

Exclusion criteria

* Family members do not agree to let the child participate in the study. * Severe respiratory failure required mechanical ventilation. * The patient left on his own during treatment.

Design outcomes

Primary

MeasureTime frameDescription
Improve clinical severity score after three days of treatment with nebulized 3% hypertonic saline.three daysThe clinical severity score is a validated, self-reported instrument assessing clinical severity over treatment. Possible scores range from 0 (mild) to 12 (severity).

Secondary

MeasureTime frameDescription
Shorten the mean length of hospital stays in infants with bronchiolitis after treatment with nebulized 3% hypertonic saline.From admission to discharge, up to 14 daysThe mean length of hospital stays is the days from admission to discharge of all participants.

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026