Comparative Efficacy of Hypertonic Saline vs Adrenaline Nebulization in Acute Bronchiolitis

Acute Bronchiolitis Due to Respiratory Syncytial Virus Clinical Trial

— children  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06267118
• Other study ID #: Treatment of Bronchiolitis
• Status: Recruiting
• Phase: Phase 3
• Start date: November 1, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: February 2024
• Source: Combined Military Hospital, Pakistan
• Contact: Syed Qamar Zaman
• Phone: 00923365307823
• Email: dr.qamarzaman[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Bronchiolitis Due to Respiratory Syncytial Virus
• Bronchiolitis

Intervention

Drug:
• Hypertonic Saline Solution, 1 Ml
Dilute 0.3 ml hypertonic saline with 3 ml normal saline for nebulization
• Adrenaline
dilute 0.3 ml adrenaline with 3 ml normal saline for nebulization

Locations

Country	Name	City	State
Pakistan	Combined Military Hospital	Nowshera	KPK

Sponsors (1)

Lead Sponsor	Collaborator
Combined Military Hospital, Pakistan

Country where clinical trial is conducted

Pakistan, 

References & Publications (7)

Anil AB, Anil M, Saglam AB, Cetin N, Bal A, Aksu N. High volume normal saline alone is as effective as nebulized salbutamol-normal saline, epinephrine-normal saline, and 3% saline in mild bronchiolitis. Pediatr Pulmonol. 2010 Jan;45(1):41-7. doi: 10.1002/ — View Citation

Florin TA, Plint AC, Zorc JJ. Viral bronchiolitis. Lancet. 2017 Jan 14;389(10065):211-224. doi: 10.1016/S0140-6736(16)30951-5. Epub 2016 Aug 20. — View Citation

Fretzayas A, Moustaki M. Etiology and clinical features of viral bronchiolitis in infancy. World J Pediatr. 2017 Aug;13(4):293-299. doi: 10.1007/s12519-017-0031-8. Epub 2017 May 4. — View Citation

Grewal S, Ali S, McConnell DW, Vandermeer B, Klassen TP. A randomized trial of nebulized 3% hypertonic saline with epinephrine in the treatment of acute bronchiolitis in the emergency department. Arch Pediatr Adolesc Med. 2009 Nov;163(11):1007-12. doi: 10 — View Citation

Hariprakash S, Alexander J, Carroll W, Ramesh P, Randell T, Turnbull F, Lenney W. Randomized controlled trial of nebulized adrenaline in acute bronchiolitis. Pediatr Allergy Immunol. 2003 Apr;14(2):134-9. doi: 10.1034/j.1399-3038.2003.00014.x. — View Citation

Piedimonte G, Perez MK. Respiratory syncytial virus infection and bronchiolitis. Pediatr Rev. 2014 Dec;35(12):519-30. doi: 10.1542/pir.35-12-519. No abstract available. Erratum In: Pediatr Rev. 2015 Feb;36(2):85. — View Citation

Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. Nebulised hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2017 Dec 21;12(12):CD006458. doi: 10.1002/14651858.CD006458.pub4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wood-Downes-Ferres clinical score calculation	A score of 0-3 mild, 4-6 moderately ill, >6 severely ill	at 24 and 48 hours of treatment
Secondary	total length of hospitalization	less than 1 week, more than 1 week,	less than 7 days, 7-10 days, 10-14 days

External Links

•   RCTnebulized epinephrine versus nebulized hypertonic saline in infants with acute bronchiolitis
•   Viral bronchiolitis in children: A common condition with few therapeutic options