NCT06267118

Comparative Efficacy of Hypertonic Saline vs Adrenaline Nebulization in Acute Bronchiolitis

A Randomized Controlled Trial on the Comparative Efficacy of Hypertonic Saline vs Adrenaline Nebulization in Acute Bronchiolitis in Children

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Combined Military Hospital, Pakistan · Academic / Other
• Sex: All
• Age: 1 Month – 2 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare the efficacy of hypertonic saline nebulization with adrenaline nebulization in the treatment of acute bronchiolitis in children. Main aim is to evaluate the following in both group of patients 1. Improvement in Wood-Downes clinical score (WDF score) in bronchiolitis 2. Length of Hospitalization

Detailed description

This is a double-blind clinical trial that will include all admitted patients with acute bronchiolitis, meeting inclusion criteria, admitted in Pediatrics department Combined Military Hospital Nowshera. Patients will be divided into two groups randomly. Group I patients will be nebulized with drug adrenaline every 6 hours and group II patients will be nebulized with hypertonic saline every 6 hours. After 24 hours and 48 hours of nebulization, researchers will record WDF score by measuring respiratory rate, heart rate, chest retractions, chest auscultation findings and SPO₂ levels. All data will be recorded on a research Performa including length of hospital stay. Data will be entered on SPSS to calculate results. Independent sample t-test was used to measure the effect of two drugs on the length of hospital stay and improvement of respiratory score with a 95% confidence interval. P value less than 0.05 will be considered as significant.

Conditions

• Acute Bronchiolitis Due to Respiratory Syncytial Virus

Interventions

Type	Name	Description
DRUG	Hypertonic Saline Solution, 1 Ml	Dilute 0.3 ml hypertonic saline with 3 ml normal saline for nebulization
DRUG	Adrenaline	dilute 0.3 ml adrenaline with 3 ml normal saline for nebulization

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-11-30
• Completion: 2024-12-31
• First posted: 2024-02-20
• Last updated: 2024-08-22

Locations

1 site across 1 country: Pakistan