Nebulised 3% Hypertonic Saline in Infants With Acute Bronchiolitis

NCT06558461 | Completed Phase 2 FDA Drug

• 1 other identifier: 173
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Bronchiolitis

Keywords

Bronchiolitis; 3% hypertonic saline

Outcome Measures

Primary Outcomes (1)

• Improve clinical severity score after three days of treatment with nebulized 3% hypertonic saline.

  The clinical severity score is a validated, self-reported instrument assessing clinical severity over treatment. Possible scores range from 0 (mild) to 12 (severity).

  three days

Secondary Outcomes (1)

• 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

Study Arms (2)

3% hypertonic saline

EXPERIMENTAL

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.

Drug: 3% Sodium Chloride

Control

ACTIVE COMPARATOR

Children will only receive standard medical care.

Other: Standard care

Interventions

3% Sodium Chloride DRUG

4ml nebulized three times daily

3% hypertonic saline

Standard care OTHER

Standard care

Control

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Can Tho University of Medicine and Pharmacy: lead

Study Sites (1)

Can Tho Children's Hospital

Can Tho, 900000, Vietnam

Location

MeSH Terms

Conditions

Bronchiolitis

Interventions

Sodium Chloride; Standard of Care

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Van VuTuong Le, MD

  Can Tho University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 16, 2024
• Study Start: June 1, 2022
• Primary Completion: May 27, 2024
• Study Completion: May 28, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Starting 6 months after publication

Locations

VN (1)