Comparative Efficacy of Hypertonic Saline vs Adrenaline Nebulization in Acute Bronchiolitis (children)

August 21, 2024 updated by: Syed Qamar Zaman, Combined Military Hospital, Pakistan

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • KPK
      • Nowshera, KPK, Pakistan, 24110
        • Recruiting
        • Combined Military Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Syed Qamar Zaman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hypertonic saline nebulization group
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
Drug: Hypertonic Saline Solution, 1 Ml
Dilute 0.3 ml hypertonic saline with 3 ml normal saline for nebulization
Other Names:
  • Drug A
Active Comparator: Adrenaline nebulization group
Second group of patients will be nebulized with adrenaline every 6 hours and data will be recorded on a Performa
Drug: Adrenaline
dilute 0.3 ml adrenaline with 3 ml normal saline for nebulization
Other Names:
  • Drug B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wood-Downes-Ferres clinical score calculation
Time Frame: at 24 and 48 hours of treatment
A score of 0-3 mild, 4-6 moderately ill, >6 severely ill
at 24 and 48 hours of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total length of hospitalization
Time Frame: less than 7 days, 7-10 days, 10-14 days
less than 1 week, more than 1 week,
less than 7 days, 7-10 days, 10-14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Combined Military Hospital, Pakistan

Investigators

  • Study Director: Prof Shahid Mahmud, Military Hospital Rawalpindi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 7, 2024

First Submitted That Met QC Criteria

February 18, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Treatment of Bronchiolitis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

After informed consent of participants and ethical committee approval, it will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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