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
About this trial
This is an interventional treatment trial for Acute Bronchiolitis
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
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
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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