Hypertonic Saline Inhalation in Acute Bronchiolitis

NCT ID: NCT03880903

Last Updated: 2020-02-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-20
• Study Completion Date: 2021-09-20

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.

Conditions

Acute Bronchiolitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

normal saline with bronchdilator

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

Group Type: EXPERIMENTAL

normal saline and salbutamol

Intervention Type: DRUG

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

hypertonic saline with bronchodilator

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

Group Type: EXPERIMENTAL

hypertonic saline and salbutamol

Intervention Type: DRUG

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

hypertonic saline only

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

Group Type: EXPERIMENTAL

Hypertonic saline

Intervention Type: DRUG

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

Interventions

normal saline and salbutamol

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

Intervention Type: 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

Intervention Type: DRUG

Hypertonic saline

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

Intervention Type: DRUG

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

• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

MASamoael

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

mohamed El Tellawy, professor

Role: CONTACT

mohamed.mohamed51@med.au.eg

00201003486595

Duaa Raafat, Assis prof

Role: CONTACT

doaa.ahmed3@med.au.eg

00201223112124

References

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.

Reference Type: RESULT

PMID: 24093893 (View on PubMed)

Smyth RL, Openshaw PJ. Bronchiolitis. Lancet. 2006 Jul 22;368(9532):312-22. doi: 10.1016/S0140-6736(06)69077-6.

Reference Type: RESULT

PMID: 16860701 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15654403 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20100768 (View on PubMed)

Other Identifiers

HS

Identifier Type: -

Identifier Source: org_study_id