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Hypertonic Saline Inhalation in Acute Bronchiolitis

A

Assiut University

Status and phase

Unknown
Phase 4

Conditions

Acute Bronchiolitis

Treatments

Drug: Hypertonic saline
Drug: normal saline and salbutamol
Drug: hypertonic saline and salbutamol

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

75 estimated patients

Sex

All

Ages

Under 24 months old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 3 patient groups

normal saline with bronchdilator
Experimental group
Description:
will recieve treatment with nebulized brochodilator(salbutamol) and normal saline every 4 to 6 hours
Treatment:
Drug: normal saline and salbutamol
hypertonic saline with bronchodilator
Experimental group
Description:
will recieve treatment with nebulized bronchodilator(salbutamol) and hypertonic saline every 4 to 6 hours
Treatment:
Drug: hypertonic saline and salbutamol
hypertonic saline only
Experimental group
Description:
will recieve treatment with nebulized hypertonic saline 3% in adose of 4 ml every 4 to 6 hours
Treatment:
Drug: Hypertonic saline

Trial contacts and locations

0

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Central trial contact

mohamed El Tellawy, professor; Duaa Raafat, Assis prof

Data sourced from clinicaltrials.gov

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