Hypertonic Saline Inhalation in Acute Bronchiolitis

February 9, 2020 updated by: MASamoael, Assiut University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital length of stay
Time Frame: 24 hours
time taken to discharge or ready to be discharged
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 20, 2020

Primary Completion (Anticipated)

March 20, 2021

Study Completion (Anticipated)

September 20, 2021

Study Registration Dates

First Submitted

March 17, 2019

First Submitted That Met QC Criteria

March 17, 2019

First Posted (Actual)

March 19, 2019

Study Record Updates

Last Update Posted (Actual)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 9, 2020

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Bronchiolitis

Clinical Trials on normal saline and salbutamol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe