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RecruitingNCT06267118childrenUpdated Aug 22, 2024

Comparative Efficacy of Hypertonic Saline vs Adrenaline Nebulization in Acute Bronchiolitis

A Phase 3 interventional study of Hypertonic Saline Solution, 1 Ml and Adrenaline in Acute Bronchiolitis Due to Respiratory Syncytial Virus, sponsored by Combined Military Hospital, Pakistan. Recruiting at 1 site in Pakistan. Open to participants aged 1 Month to 2 Years. Per ClinicalTrials.gov, last updated 2024-08-22.

Sponsored by Combined Military Hospital, Pakistan · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started Nov 2023; still recruiting 3 years later.
Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
1 Month to 2 Years
Sex
All
01

Study 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
Read the 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.

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Conditions studied

  • Acute Bronchiolitis Due to Respiratory Syncytial Virus

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Keywords

  • Wood-Downes Clinical scoring System
03

In context

Bronchiolitis

289 studies on the registry are indexed under Bronchiolitis; 51 are open to participants now.

This study's planned enrollment of 60 is below the median of 100 across 195 interventional studies indexed under Bronchiolitis.

Browse Bronchiolitis studies →

Lead sponsor

Combined Military Hospital, Pakistan is the lead sponsor of 15 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Month to 2 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All children admitted in PICU with acute bronchiolitis

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Hypertonic saline nebulization group

    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

  • Active comparator
    Adrenaline nebulization group

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

    Drug: Adrenaline

Interventions

  • DrugHypertonic Saline Solution, 1 Ml

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

    Also known as: Drug A

  • dilute 0.3 ml adrenaline with 3 ml normal saline for nebulization

    Also known as: Drug B

06

What researchers measure

Primary outcomes

  1. Wood-Downes-Ferres clinical score calculation

    A score of 0-3 mild, 4-6 moderately ill, \>6 severely ill

    Time frame: at 24 and 48 hours of treatment

Secondary outcomes

  1. total length of hospitalization

    less than 1 week, more than 1 week,

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

07

Study locations

1 of 1 sites recruiting
  • Combined Military Hospital
    Nowshera, KPK 24110, Pakistan
    Recruiting
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References and documents

Publications

  • 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. doi: 10.1542/pir.36-2-85. PubMed 25452661 ↗
  • 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. PubMed 19953579 ↗
  • 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. PubMed 27549684 ↗
  • 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. PubMed 19884591 ↗
  • 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. PubMed 29265171 ↗
  • 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. PubMed 12675760 ↗
  • 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. PubMed 28470580 ↗

Individual participant data

Plan to share: Undecided — After informed consent of participants and ethical committee approval, it will be shared.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06267118
Lead sponsor
Combined Military Hospital, Pakistan
Responsible party
Syed Qamar Zaman (Assistant Professor & Head of Pediatrics Department, Combined Military Hospital, Pakistan) — Principal investigator
First posted
Feb 20, 2024
Start date
Nov 1, 2023
Primary completion
Nov 30, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Aug 22, 2024

Study contacts

Syed Qamar Zaman
Contact
dr.qamarzaman@hotmail.com
00923365307823
Madeeha Qamar
Contact
affifamadhu89@gmail.com
00923353459662
Prof Shahid Mahmud
study director · Military Hospital Rawalpindi

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Epinephrine

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