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Hypertonic Saline Inhalation in Acute Bronchiolitis

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ClinicalTrials.gov Identifier: NCT03880903
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
MASamoael, Assiut University

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

Condition or disease Intervention/treatment Phase
Acute Bronchiolitis Drug: normal saline and salbutamol Drug: hypertonic saline and salbutamol Drug: Hypertonic saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Study on the Use of Hypertonic Saline Inhalation in Acute Bronchiolitis in Children
Estimated Study Start Date : March 20, 2019
Estimated Primary Completion Date : March 20, 2021
Estimated Study Completion Date : September 20, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: normal saline with bronchdilator
will recieve treatment with nebulized brochodilator(salbutamol) and normal saline every 4 to 6 hours
Drug: normal saline and salbutamol
patients will recieve treatment with nebulized salbutamol and normal saline every 4 to 6 in hours

Experimental: hypertonic saline with bronchodilator
will recieve treatment with nebulized bronchodilator(salbutamol) and hypertonic saline every 4 to 6 hours
Drug: hypertonic saline and salbutamol
patients will recieve treatment with nebulized salbutamol and hypertonic saline 3% in adose of 4ml every 4 to 6 hours

Experimental: hypertonic saline only
will recieve treatment with nebulized hypertonic saline 3% in adose of 4 ml every 4 to 6 hours
Drug: Hypertonic saline
patients will recieve treatment with nebulized hypertonic saline 3% in adose of 4ml every 4 to 6 hours




Primary Outcome Measures :
  1. Hospital length of stay [ Time Frame: 24 hours ]
    time taken to discharge or ready to be discharged



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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880903


Contacts
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Contact: mohamed El Tellawy, professor 00201003486595 mohamed.mohamed51@med.au.eg
Contact: Duaa Raafat, Assis prof 00201223112124 doaa.ahmed3@med.au.eg

Sponsors and Collaborators
Assiut University

Publications of Results:
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Responsible Party: MASamoael, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03880903     History of Changes
Other Study ID Numbers: HS
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019

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

Additional relevant MeSH terms:
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Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action