Comparative Efficacy of Hypertonic Saline vs Adrenaline Nebulization in Acute Bronchiolitis

NCT06267118 | Recruiting Phase 3 DMC

• 1 other identifier: Treatment of Bronchiolitis
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.Improvement in Wood-Downes clinical score (WDF score) in bronchiolitis
2. 2.Length of Hospitalization

Conditions

Acute Bronchiolitis Due to Respiratory Syncytial Virus

Keywords

Wood-Downes Clinical scoring System

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• total length of hospitalization

  less than 7 days, 7-10 days, 10-14 days

Study Arms (2)

Hypertonic saline nebulization group

ACTIVE COMPARATOR

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

Adrenaline nebulization group

ACTIVE COMPARATOR

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

Drug: Adrenaline

Interventions

Hypertonic Saline Solution, 1 Ml DRUG

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

Also known as: Drug A

Hypertonic saline nebulization group

Adrenaline DRUG

dilute 0.3 ml adrenaline with 3 ml normal saline for nebulization

Also known as: Drug B

Adrenaline nebulization group

Eligibility Criteria

• Age: 1 Month - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All children admitted in PICU with acute bronchiolitis

You may not qualify if:

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

Sponsors & Collaborators

• Combined Military Hospital, Pakistan: lead

Study Sites (1)

Combined Military Hospital

Nowshera, KPK, 24110, Pakistan

RECRUITING

Related Publications (7)

• 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.

  PMID: 25452661 RESULT

• 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/ppul.21108.

  PMID: 19953579 RESULT

• 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.

  PMID: 27549684 RESULT

• 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: 10.1001/archpediatrics.2009.196.

  PMID: 19884591 RESULT

• 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.

  PMID: 29265171 RESULT

• 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.

  PMID: 12675760 RESULT

• 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.

  PMID: 28470580 RESULT

Related Links

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

MeSH Terms

Interventions

Saline Solution, Hypertonic; Epinephrine

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Prof Shahid Mahmud

  Military Hospital Rawalpindi

  STUDY DIRECTOR

Central Study Contacts

Syed Qamar Zaman

CONTACT

00923365307823; dr.qamarzaman@hotmail.com

Madeeha Qamar

CONTACT

00923353459662; affifamadhu89@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor & Head of Pediatrics Department

Model Details: 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.

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: February 20, 2024
• Study Start: November 1, 2023
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

PA (1)