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Hypertonic Saline Inhalation in Acute Bronchiolitis

Primary Purpose

Acute Bronchiolitis

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
normal saline and salbutamol
hypertonic saline and salbutamol
Hypertonic saline
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Bronchiolitis

Eligibility Criteria

undefined - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • infants less than 24 months of age with adiagnosis of acute bronchiolitis

Exclusion Criteria:

  • other infants and children above 24 months of age
  • patients with other diseases than acute bronchiolitis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    normal saline with bronchdilator

    hypertonic saline with bronchodilator

    hypertonic saline only

    Arm Description

    will recieve treatment with nebulized brochodilator(salbutamol) and normal saline every 4 to 6 hours

    will recieve treatment with nebulized bronchodilator(salbutamol) and hypertonic saline every 4 to 6 hours

    will recieve treatment with nebulized hypertonic saline 3% in adose of 4 ml every 4 to 6 hours

    Outcomes

    Primary Outcome Measures

    Hospital length of stay
    time taken to discharge or ready to be discharged

    Secondary Outcome Measures

    Full Information

    First Posted
    March 17, 2019
    Last Updated
    February 9, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03880903
    Brief Title
    Hypertonic Saline Inhalation in Acute Bronchiolitis
    Official Title
    A Prospective Study on the Use of Hypertonic Saline Inhalation in Acute Bronchiolitis in Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 20, 2020 (Anticipated)
    Primary Completion Date
    March 20, 2021 (Anticipated)
    Study Completion Date
    September 20, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Acute bronchiolitis is a viral infection that occurs in children most commonly in the first 2 years of life and is characterized by respiratory symptoms, resulting in wheezing and/or crackles upon auscultation. It is usually a self limiting illness. However, this condition may be associated with several severe complications, such as apnea,respiratory failure, or secondary bacterial infection
    Detailed Description
    Acute bronchiolitis is a viral infection that occurs in children most commonly in the first 2 years of life and is characterized by respiratory symptoms, resulting in wheezing and/or crackles upon auscultation. It is usually a self limiting illness. However, this condition may be associated with several severe complications, such as apnea,respiratory failure, or secondary bacterial infection. Bronchiolitis is a significant cause of respiratory disease worldwide. according to the World Health Organization bullet in, an estimated 150 million new cases occur annually; 11-20 million (7-13%) of these cases are severe enough to require hospital admission. Worldwide, 95% of all cases occur in developing countries. Typically, initial clinical manifestations include upper respiratory tract symptoms such as cough, nasal congestion, and low-grade fever lasting 1 to 3 days, followed by expiratory wheezing, nasal flaring, fine crackles, oxygen saturation on presentation<94%, tachypnea, increased work of breathing, use of accessory muscles, and retractions in some patients. The need for hospitalization depends on the presence of respiratory symptoms (degree of retractions, increased respiratory effort, decreased oxygen saturation), cyanosis, restlessness or lethargy, and underlying disease states, including apnea. Since no definitive antiviral therapy exists for most causes of bronchiolitis, management of these infants should be directed toward symptomatic relief and maintenance of hydration and oxygenation. One medication that has demonstrated promising results in the management of acute bronchiolitis is nebulized hypertonic saline , Its hyperosmolarity helps to absorb water from the mucosal and submucosal space, thereby increasing mucociliary function by clearing fluids accumulated in the airway and mucus plugs in the lungs. Hypertonic saline can also induce cough to help enhance mucus clearance. The American Academy Of Pediatrics guidelines recommend administration of hypertonic saline in hospitalized bronchiolitis patients. The most common dosage studied is hypertonic saline 3% 4 mL per dose inhaled by nebulizer every 4 to 6 hours, which may take ≥24 hours to work and is typically continued while the child is hospitalized.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Bronchiolitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    75 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    normal saline with bronchdilator
    Arm Type
    Experimental
    Arm Description
    will recieve treatment with nebulized brochodilator(salbutamol) and normal saline every 4 to 6 hours
    Arm Title
    hypertonic saline with bronchodilator
    Arm Type
    Experimental
    Arm Description
    will recieve treatment with nebulized bronchodilator(salbutamol) and hypertonic saline every 4 to 6 hours
    Arm Title
    hypertonic saline only
    Arm Type
    Experimental
    Arm Description
    will recieve treatment with nebulized hypertonic saline 3% in adose of 4 ml every 4 to 6 hours
    Intervention Type
    Drug
    Intervention Name(s)
    normal saline and salbutamol
    Intervention Description
    patients will recieve treatment with nebulized salbutamol and normal saline every 4 to 6 in hours
    Intervention Type
    Drug
    Intervention Name(s)
    hypertonic saline and salbutamol
    Intervention Description
    patients will recieve treatment with nebulized salbutamol and hypertonic saline 3% in adose of 4ml every 4 to 6 hours
    Intervention Type
    Drug
    Intervention Name(s)
    Hypertonic saline
    Intervention Description
    patients will recieve treatment with nebulized hypertonic saline 3% in adose of 4ml every 4 to 6 hours
    Primary Outcome Measure Information:
    Title
    Hospital length of stay
    Description
    time taken to discharge or ready to be discharged
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    24 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: infants less than 24 months of age with adiagnosis of acute bronchiolitis Exclusion Criteria: other infants and children above 24 months of age patients with other diseases than acute bronchiolitis
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    mohamed El Tellawy, professor
    Phone
    00201003486595
    Email
    mohamed.mohamed51@med.au.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Duaa Raafat, Assis prof
    Phone
    00201223112124
    Email
    doaa.ahmed3@med.au.eg

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24093893
    Citation
    Teshome G, Gattu R, Brown R. Acute bronchiolitis. Pediatr Clin North Am. 2013 Oct;60(5):1019-34. doi: 10.1016/j.pcl.2013.06.005. Epub 2013 Jul 24.
    Results Reference
    result
    PubMed Identifier
    16860701
    Citation
    Smyth RL, Openshaw PJ. Bronchiolitis. Lancet. 2006 Jul 22;368(9532):312-22. doi: 10.1016/S0140-6736(06)69077-6.
    Results Reference
    result
    PubMed Identifier
    15654403
    Citation
    Rudan I, Tomaskovic L, Boschi-Pinto C, Campbell H; WHO Child Health Epidemiology Reference Group. Global estimate of the incidence of clinical pneumonia among children under five years of age. Bull World Health Organ. 2004 Dec;82(12):895-903. Epub 2005 Jan 5.
    Results Reference
    result
    PubMed Identifier
    20100768
    Citation
    Zorc JJ, Hall CB. Bronchiolitis: recent evidence on diagnosis and management. Pediatrics. 2010 Feb;125(2):342-9. doi: 10.1542/peds.2009-2092. Epub 2010 Jan 25.
    Results Reference
    result

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    Hypertonic Saline Inhalation in Acute Bronchiolitis

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