Comparative Efficacy of Hypertonic Saline vs Adrenaline Nebulization in Acute Bronchiolitis

NCT ID: NCT06267118

Last Updated: 2024-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Acute Bronchiolitis Due to Respiratory Syncytial Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
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.

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Hypertonic Saline Solution, 1 Ml

Intervention Type DRUG

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

Adrenaline nebulization group

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

Group Type ACTIVE_COMPARATOR

Adrenaline

Intervention Type DRUG

dilute 0.3 ml adrenaline with 3 ml normal saline for nebulization

Interventions

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Hypertonic Saline Solution, 1 Ml

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

Intervention Type DRUG

Adrenaline

dilute 0.3 ml adrenaline with 3 ml normal saline for nebulization

Intervention Type DRUG

Other Intervention Names

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Drug A Drug B

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Combined Military Hospital, Pakistan

OTHER

Sponsor Role lead

Responsible Party

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Syed Qamar Zaman

Assistant Professor & Head of Pediatrics Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Prof Shahid Mahmud

Role: STUDY_DIRECTOR

Military Hospital Rawalpindi

Locations

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Combined Military Hospital

Nowshera, KPK, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Syed Qamar Zaman

Role: CONTACT

00923365307823

Madeeha Qamar

Role: CONTACT

00923353459662

Facility Contacts

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Syed Qamar Zaman

Role: primary

00923365307823

Shahid Mahmud

Role: backup

00923315301289

References

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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.

Reference Type RESULT
PMID: 25452661 (View on PubMed)

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.

Reference Type RESULT
PMID: 19953579 (View on PubMed)

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.

Reference Type RESULT
PMID: 27549684 (View on PubMed)

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.

Reference Type RESULT
PMID: 19884591 (View on PubMed)

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.

Reference Type RESULT
PMID: 29265171 (View on PubMed)

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.

Reference Type RESULT
PMID: 12675760 (View on PubMed)

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.

Reference Type RESULT
PMID: 28470580 (View on PubMed)

Related Links

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https://www.ijpediatrics.com/index.php/ijcp/article/view/4218

RCTnebulized epinephrine versus nebulized hypertonic saline in infants with acute bronchiolitis

http://doi.org/10.1016/j.earlhumdev.2013.07.016

Viral bronchiolitis in children: A common condition with few therapeutic options

Other Identifiers

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Treatment of Bronchiolitis

Identifier Type: -

Identifier Source: org_study_id

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