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

NCT ID: NCT06665711

Last Updated: 2024-10-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-03
• Study Completion Date: 2025-03-10

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.

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

Conditions

BRONCHIOLITIS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

3% Hypertonic Saline

Intervention Type: 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: 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.

Group Type: ACTIVE_COMPARATOR

Intervention: Salbutamol (Ventolin)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Health Sciences Lahore

OTHER

Sponsor Role: lead

Responsible Party

Qasim Niaz

Post Graduate Resident Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Qasim Niaz, Post Graduate Resident

Role: CONTACT

info@uhs.edu.pk

111-33-33-66

Other Identifiers

Exp125

Identifier Type: -

Identifier Source: org_study_id