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

ConditionBRONCHIOLITIS
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-24
SponsorUniversity of Health Sciences Lahore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Infants aged 2-24 months

Gender; Both Male and female patients.

Presenting with bronchiolitis (as per operational definition)

Disqualifiers

Congenital heart disease

Immune deficiency

Trial design

Design model

Parallel

Treatments tested in this trial

  • 3% Hypertonic Saline

    Procedure/Surgery

    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)

    Procedure/Surgery

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Intervention: 3% Hypertonic SalineActive comparator 1 intervention
Group B: Intervention: Salbutamol (Ventolin)Active comparator 1 intervention

Trial outcomes

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.

Time frame
5 days

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: