Comparative Efficacy of Hypertonic Saline vs Adrenaline Nebulization in Acute Bronchiolitis

Phase 3

Recruiting

• Conditions: Acute Bronchiolitis Due to Respiratory Syncytial Virus
• Interventions: Drug: Hypertonic Saline Solution, 1 Ml; Drug: Adrenaline

• Registration Number: NCT06267118
• Lead Sponsor: Combined Military Hospital, Pakistan

Brief 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.

Study Timeline

• Study Start: 2023-11-01
• Study First Submitted: 2024-01-07
• Study First Submitted QC: 2024-02-18
• Study First Posted: 2024-02-20
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• All children admitted in PICU with acute bronchiolitis

Exclusion Criteria

• children with co-exiting illnesses like

  1. Congenital Heart Disease
  2. Immunodeficiency
  3. other Infectious disease like Meningitis, encephalitis, Pneumonia, TORCH
  4. Kidneys or liver problem
  5. Seizures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypertonic saline nebulization group	Hypertonic Saline Solution, 1 Ml	First group of patients diagnosed as acute bronchiolitis will be nebulized with hypertonic saline every 6 hours and data will be recorded on a Performa
Adrenaline nebulization group	Adrenaline	Second group of patients will be nebulized with adrenaline every 6 hours and data will be recorded on a Performa

Primary Outcome Measures

Name	Time	Method
Wood-Downes-Ferres clinical score calculation	at 24 and 48 hours of treatment	A score of 0-3 mild, 4-6 moderately ill, \>6 severely ill

Secondary Outcome Measures

Name	Time	Method
total length of hospitalization	less than 7 days, 7-10 days, 10-14 days	less than 1 week, more than 1 week,

Trial Locations

Locations (1)

Combined Military Hospital; 🇵🇰 Nowshera, KPK, Pakistan