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Hypertonic Saline Inhalation in Acute Bronchiolitis

A Prospective Study on the Use of Hypertonic Saline Inhalation in Acute Bronchiolitis in Children

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03880903
Enrollment
75
Registered
2019-03-19
Start date
2020-07-20
Completion date
2021-09-20
Last updated
2020-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Bronchiolitis

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.

Interventions

DRUGnormal saline and salbutamol

patients will recieve treatment with nebulized salbutamol and normal saline every 4 to 6 in hours

DRUGhypertonic saline and salbutamol

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

DRUGHypertonic saline

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 24 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Hospital length of stay24 hourstime taken to discharge or ready to be discharged

Contacts

Primary Contactmohamed El Tellawy, professor
mohamed.mohamed51@med.au.eg00201003486595
Backup ContactDuaa Raafat, Assis prof
doaa.ahmed3@med.au.eg00201223112124

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026