Evaluating the Efficacy of Nebulised 3% Hypertonic Saline for Acute Bronchiolitis in Infants: A Study at Can Tho Children's Hospital, 2022-2024
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Improve clinical severity score after three days of treatment with nebulized 3% hypertonic saline.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Month to 24 Months (Child)
- Sex
- All
- Accepts 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.
Arms & Interventions
Control
Children will only receive standard medical care.
Intervention: Standard care (Other)
3% hypertonic saline
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.
Intervention: 3% Sodium Chloride (Drug)
Outcomes
Primary Outcomes
Improve clinical severity score after three days of treatment with nebulized 3% hypertonic saline.
Time Frame: 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 Outcomes
- 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)