Nebulised 3% Hypertonic Saline in Infants With Acute Bronchiolitis

Phase 2

Completed

• Conditions: Acute Bronchiolitis
• Interventions: Drug: 3% Sodium Chloride; Other: Standard care

• Registration Number: NCT06558461
• Lead Sponsor: Can Tho University of Medicine and Pharmacy

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.

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2024-05-27
• Study Completion: 2024-05-28
• Status Verified: 2024-08
• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-14
• Last Update Submitted: 2024-08-14
• Study First Posted: 2024-08-16
• Last Update Posted: 2024-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3% hypertonic saline	3% Sodium Chloride	Children will receive standard medical care coordinating with nebulizing 3% hypertonic saline in the treatment of bronchiolitis. They received 4ml of 3% Sodium chloride, nebulized three times daily until discharge.
Control	Standard care	Children will only receive standard medical care.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 days	The mean length of hospital stays is the days from admission to discharge of all participants.

Trial Locations

Locations (1)

Can Tho Children's Hospital; 🇻🇳 Can Tho, Vietnam