Nebulised 3% Hypertonic Saline in Infants With Acute Bronchiolitis

NCT ID: NCT06558461

Last Updated: 2024-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-05-28

Brief Summary

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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

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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.

Conditions

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Acute Bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

3% Sodium Chloride

Intervention Type DRUG

4ml nebulized three times daily

Control

Children will only receive standard medical care.

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type OTHER

Standard care

Interventions

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3% Sodium Chloride

4ml nebulized three times daily

Intervention Type DRUG

Standard care

Standard care

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Can Tho University of Medicine and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Van VuTuong Le, MD

Role: PRINCIPAL_INVESTIGATOR

Can Tho University of Medicine and Pharmacy

Locations

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Can Tho Children's Hospital

Can Tho, , Vietnam

Site Status

Countries

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Vietnam

Other Identifiers

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173

Identifier Type: -

Identifier Source: org_study_id

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