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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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06267118
Acronym
children
Enrollment
60
Registered
2024-02-20
Start date
2023-11-01
Completion date
2024-12-31
Last updated
2024-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Bronchiolitis Due to Respiratory Syncytial Virus

Keywords

Wood-Downes Clinical scoring System

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.

Interventions

Dilute 0.3 ml hypertonic saline with 3 ml normal saline for nebulization

DRUGAdrenaline

dilute 0.3 ml adrenaline with 3 ml normal saline for nebulization

Sponsors

Combined Military Hospital, Pakistan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

Investigator will make all the protocol and research Performa. Drugs will already be prepared for nebulization and labelled by investigator. Researcher /care provider will nebulize the patients of both groups randomly and record the results accordingly.

Intervention model description

Patients with acute bronchiolitis after informed written consent will be divided into two groups randomly. Group I will be nebulized with adrenaline every 6 hours and group II will nebulized with hypertonic saline every 6 hours. After 24 hours and 48 hours of nebulization, WDF score will be recorded by measuring respiratory rate, heart rate, chest retractions, chest auscultation findings and SPO₂ levels. Researcher will record all data on a specified Performa.

Eligibility

Sex/Gender
ALL
Age
1 Months to 2 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Wood-Downes-Ferres clinical score calculationat 24 and 48 hours of treatmentA score of 0-3 mild, 4-6 moderately ill, \>6 severely ill

Secondary

MeasureTime frameDescription
total length of hospitalizationless than 7 days, 7-10 days, 10-14 daysless than 1 week, more than 1 week,

Countries

Pakistan

Contacts

Primary ContactSyed Qamar Zaman
dr.qamarzaman@hotmail.com00923365307823
Backup ContactMadeeha Qamar
affifamadhu89@gmail.com00923353459662

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026