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

NCT06665711 | Not Yet Recruiting

• 1 other identifier: Exp125
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

BRONCHIOLITIS

Keywords

BRONCHIOLITIS

Outcome Measures

Primary Outcomes (1)

• Change in Respiratory Distress Assessment Instrument (RDAI) Score

  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

Study Arms (2)

Intervention: 3% Hypertonic Saline

ACTIVE COMPARATOR

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

Intervention: Salbutamol (Ventolin)

ACTIVE COMPARATOR

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)

Interventions

3% Hypertonic Saline PROCEDURE

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.

Intervention: 3% Hypertonic Saline

Intervention: Salbutamol (Ventolin) PROCEDURE

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.

Intervention: Salbutamol (Ventolin)

Eligibility Criteria

• Age: 2 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Infant with metabolic disorder
• Congenital heart disease
• Immune deficiency

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

MeSH Terms

Conditions

Bronchiolitis

Interventions

Saline Solution, Hypertonic; Albuterol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Central Study Contacts

Qasim Niaz, Post Graduate Resident

CONTACT

111-33-33-66; info@uhs.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Resident Pediatrics

Model Details: This study will employ a randomized controlled trial (RCT) design, which is considered the gold standard for evaluating the efficacy of interventions. The primary aim is to compare the effectiveness of 3% hypertonic saline against Salbutamol (Ventolin) in treating bronchiolitis in children.

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: December 3, 2024
• Primary Completion: February 6, 2025
• Study Completion: March 10, 2025
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share