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

Combined Military Hospital, Pakistan

Status and phase: Enrolling; Phase 3

Conditions: Acute Bronchiolitis Due to Respiratory Syncytial Virus

Treatments: Drug: Adrenaline; Drug: Hypertonic Saline Solution, 1 Ml

Study type: Interventional

Funder types: Other

Identifiers

NCT06267118

Treatment of Bronchiolitis

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 month to 2 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Hypertonic saline nebulization group

Active Comparator group

Description:

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

Treatment:

Drug: Hypertonic Saline Solution, 1 Ml

Adrenaline nebulization group

Active Comparator group

Description:

Second group of patients will be nebulized with adrenaline every 6 hours and data will be recorded on a Performa

Treatment:

Drug: Adrenaline