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NCT Number: NCT06267118

Comparative Efficacy of Hypertonic Saline vs Adrenaline Nebulization in Acute Bronchiolitis

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

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Key information

Conditions

Acute Bronchiolitis Due to Respiratory Syncytial Virus

Age range

1 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All children admitted in PICU with acute bronchiolitis

Exclusion criteria

  • children with co-exiting illnesses like
  • Congenital Heart Disease
  • Immunodeficiency
  • other Infectious disease like Meningitis, encephalitis, Pneumonia, TORCH
  • Kidneys or liver problem
  • Seizures

Treatment and study plan

Hypertonic Saline Solution, 1 Ml

Drug

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

Other names: Drug A

Adrenaline

Drug

dilute 0.3 ml adrenaline with 3 ml normal saline for nebulization

Other names: Drug B

Primary outcomes

  1. 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

Secondary outcomes

  1. total length of hospitalization

    Time frame: less than 7 days, 7-10 days, 10-14 days

    less than 1 week, more than 1 week,

Study contacts

Contact information is provided by the study sponsor or research team.

Madeeha Qamar

CONTACT

[email protected]

00923353459662

Syed Qamar Zaman

CONTACT

[email protected]

00923365307823

Sponsors and collaborators

Lead sponsor

Combined Military Hospital, Pakistan

Other

Registry information

Official study title

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

Acronym: children

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 20, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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