Nebulised 3% Hypertonic Saline in Infants With Acute Bronchiolitis

Can Tho University of Medicine and Pharmacy

Status and phase: Completed; Phase 3; Phase 2

Conditions: Acute Bronchiolitis

Treatments: Drug: 3% Sodium Chloride; Other: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT06558461

173

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 1 to 24 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

3% hypertonic saline

Experimental group

Description:

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.

Treatment:

Drug: 3% Sodium Chloride

Control

Active Comparator group

Description:

Children will only receive standard medical care.

Treatment:

Other: Standard care