Clinical trial NCT06267118: Comparative Efficacy of Hypertonic Saline vs Adrenaline Nebulization in Acute Bronchiolitis
Official title: A Randomized Controlled Trial on the Comparative Efficacy of Hypertonic Saline vs Adrenaline Nebulization in Acute Bronchiolitis in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acute Bronchiolitis Due to Respiratory Syncytial Virus
Keywords: Wood-Downes Clinical scoring System
Lead sponsor: Combined Military Hospital, Pakistan
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Wood-Downes-Ferres clinical score calculation
timeFrame: at 24 and 48 hours of treatment
Secondary outcomes:
measure: total length of hospitalization
timeFrame: less than 7 days, 7-10 days, 10-14 days
Other outcomes:
Locations:
city: Nowshera
country: Pakistan
facility: Combined Military Hospital
state: KPK
Study officials:
affiliation: Military Hospital Rawalpindi
name: Prof Shahid Mahmud
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.
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: 10.1001/archpediatrics.2009.196.
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.
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.
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.