Comparison of 3% Hypertonic Saline and Salbutamol in Children With Bronchiolitis

October 29, 2024 updated by: Qasim Niaz, University of Health Sciences Lahore

COMPARISON BETWEEN 3% HYPERTONIC SALINE VERSUS SALBUTAMOL IN CHILDREN WITH BRONCHIOLITIS

Bronchiolitis is a common lower respiratory tract infection that often leads to hospitalization in infants. The use of nebulized 3% hypertonic saline for treating bronchiolitis is being explored as an alternative to Salbutamol. In nebulizers, normal saline serves as a diluent, allowing water molecules or drugs to be inhaled into the lungs. However, there has been limited research on this topic, and no local trials have been conducted.

This study aims to compare the effectiveness of 3% hypertonic saline and Salbutamol in treating bronchiolitis. A randomized controlled trial will be conducted at the Department of Pediatric Medicine, Services Institute of Medical Sciences, Lahore, over one year, involving 100 infants divided into two groups: one receiving 3% hypertonic saline and the other receiving Salbutamol. The RDAI score will be evaluated before and during treatment to assess recovery time. Data will be collected using a proforma and analyzed with SPSS v25. The study aims to determine which treatment leads to faster symptom control and shorter hospital stays, with significance defined as a p-value ≤0.05. The findings will guide future treatment choices for infants with bronchiolitis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Bronchiolitis, an infection of the lower respiratory tract, is one of the common reasons why the infants are hospitalized. The effectiveness of nebulized hypertonic saline (3%) in case of bronchiolitis is under discussion around the globe. With the use of normal saline as the diluent in nebulizers and the oxygen as vaporizer, the water molecules or drugs can be breathed through the mouth or nose and spread to the respiratory tract and lungs by the airflow. This is how, Salbutamol can be replaced by 3% hypertonic saline. However, a little work has been done in the past and no trials has yet been conducted at local setup. The objective of this study is to compare the efficacy of 3% hypertonic saline versus Salbutamol in the treatment of bronchiolitis. A Randomized controlled Trial will be conducted at Department of Pediatric Medicine, Services Institute of Medical Sciences Lahore, for a period of one year. A sample size of 100 cases; 50 in each group will be included through Nonprobability consecutive sampling and will be divided randomly into two groups. In group H, 3% hypertonic saline solution will be provided. In group V, Salbutamol will be taken. Before and on the treatment day, the RDAI score will be examined for evaluation. A complete recovery time will be noted. Data will be filled in a proforma for record. SPSS v25 software will be used for data analysis. Both groups will be compared simultaneously to take mean time to control symptoms by using independent samples t-test and RDAI score. P-value ≤0.05 will be taken as significant. Therefore, selecting an appropriate drug with less chances of failure can be proved fruitful and can significantly reduce the hospital stay with early recovery. The results of this study will help to choose a better drug in future in the treatment of infants against bronchiolitis

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

  • Name: Qasim Niaz, Post Graduate Resident
  • Phone Number: 111-33-33-66
  • Email: info@uhs.edu.pk

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:

  • Infants aged 2-24 months
  • Gender; Both Male and female patients.
  • Presenting with bronchiolitis (as per operational definition)

Exclusion Criteria:

Infant with metabolic disorder

  • Congenital heart disease
  • Immune deficiency

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
Active Comparator: Intervention: 3% Hypertonic Saline
In this arm of the study, participants will receive nebulized 3% hypertonic saline as the primary treatment for bronchiolitis. The administration of hypertonic saline is aimed at reducing airway edema and improving mucociliary clearance in infants experiencing respiratory distress due to bronchiolitis.
Procedure: 3% Hypertonic Saline
In this arm of the study, participants will receive nebulized 3% hypertonic saline as the primary treatment for bronchiolitis. The administration of hypertonic saline is aimed at reducing airway edema and improving mucociliary clearance in infants experiencing respiratory distress due to bronchiolitis.
Active Comparator: Intervention: Salbutamol (Ventolin)
In this arm of the study, participants will receive nebulized Salbutamol, a bronchodilator commonly used in the management of bronchospasm associated with respiratory conditions, including bronchiolitis. The objective is to evaluate the effectiveness of Salbutamol in comparison to 3% hypertonic saline in improving the clinical outcomes of infants with bronchiolitis.
Procedure: Intervention: Salbutamol (Ventolin)
In this arm of the study, participants will receive nebulized Salbutamol, a bronchodilator commonly used in the management of bronchospasm associated with respiratory conditions, including bronchiolitis. The objective is to evaluate the effectiveness of Salbutamol in comparison to 3% hypertonic saline in improving the clinical outcomes of infants with bronchiolitis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Respiratory Distress Assessment Instrument (RDAI) Score
Time Frame: 5 days
The outcome measures of this study include the change in Respiratory Distress Assessment Instrument , assessed at baseline and on days 1, 2, 3, 4, and 5 of treatment, as well as the time to complete recovery, defined as achieving an score of less than 5.
5 days

Collaborators and Investigators

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

Sponsor

University of Health Sciences Lahore

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 (Estimated)

December 3, 2024

Primary Completion (Estimated)

February 6, 2025

Study Completion (Estimated)

March 10, 2025

Study Registration Dates

First Submitted

October 29, 2024

First Submitted That Met QC Criteria

October 29, 2024

First Posted (Actual)

October 30, 2024

Study Record Updates

Last Update Posted (Actual)

October 30, 2024

Last Update Submitted That Met QC Criteria

October 29, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Exp125

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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