Nebulised 3% Hypertonic Saline in Infants With Acute Bronchiolitis

August 14, 2024 updated by: Can Tho University of Medicine and Pharmacy

Evaluating the Efficacy of Nebulised 3% Hypertonic Saline for Acute Bronchiolitis in Infants: A Study at Can Tho Children's Hospital, 2022-2024

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Can Tho, Vietnam, 900000
        • Can Tho Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 3% Sodium Chloride
4ml nebulized three times daily
Active Comparator: Control
Children will only receive standard medical care.
Other: Standard care
Standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
three days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shorten the mean length of hospital stays in infants with bronchiolitis after treatment with nebulized 3% hypertonic saline.
Time Frame: From admission to discharge, up to 14 days
The mean length of hospital stays is the days from admission to discharge of all participants.
From admission to discharge, up to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Can Tho University of Medicine and Pharmacy

Investigators

  • Principal Investigator: Van VuTuong Le, MD, Can Tho University of Medicine and Pharmacy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

May 27, 2024

Study Completion (Actual)

May 28, 2024

Study Registration Dates

First Submitted

August 14, 2024

First Submitted That Met QC Criteria

August 14, 2024

First Posted (Actual)

August 16, 2024

Study Record Updates

Last Update Posted (Actual)

August 16, 2024

Last Update Submitted That Met QC Criteria

August 14, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 173

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected individual participant data

IPD Sharing Time Frame

Starting 6 months after publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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