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Clinical Trials/NCT03143231
NCT03143231
Completed
Not Applicable

Normal Saline Versus Hypertonic Saline in the Treatment of Bronchiolitis

Makassed General Hospital1 site in 1 country128 target enrollmentMarch 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Length of Hospital Stay
Sponsor
Makassed General Hospital
Enrollment
128
Locations
1
Primary Endpoint
Length of stay
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Background: Bronchiolitis is one of the most common and costly respiratory diseases in infants and young children. Despite the high prevalence and morbidity of bronchiolitis, therapy remains controversial. Supportive care ensuring adequate hydration and oxygenation remains the cornerstone of therapy for these infants.

Over the past 2 decades, research on bronchiolitis management has explored the use of nebulized hypertonic saline that rehydrate the airway surface liquid and improve mucociliary clearance, as well as reduce airway edema.

Aim:The aim of this study is to investigate whether the addition of frequently nebulized hypertonic saline to standard therapy affects the length of stay (LOS) of moderately ill infants hospitalized with bronchiolitis.

Detailed Description

The investigators will conduct this prospective double blind randomized clinical trial by comparing between 2 groups of patients with bronchiolitis, first group will receive 3% hypertonic saline and second group will receive 0.9% saline. Data collection includes: Name, Age, Mode of delivery, Birth weight, Current weight, Number of sibling, Immunization record, Duration of breast feeding, past medical history including number of wheezy chest, pneumonia, Parents level of education, Presence of Asthma / Allergic rhinitis in family, Pets /Smoke at home) Using the validated Respiratory Distress Assessment Instrument (RDAI) investigators will assign patients a score before and at the end of treatment. To prepare 3% sodium chloride, the investigators will dilute 60 ml 20% sodium chloride injection with 500 ml normal saline (NSS) 0.9%. Length of stay will be measured in both groups, to establish the efficacy of hypertonic saline in reducing length of stay.

Registry
clinicaltrials.gov
Start Date
March 1, 2016
End Date
May 31, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mariam Rajab

Chairperson of pediatrics department

Makassed General Hospital

Eligibility Criteria

Inclusion Criteria

  • Infants up to 24 months of age with diagnosis of acute bronchiolitis
  • In accordance with 2006 American Academy of Pediatrics (AAP) definition of bronchiolitis,we did not limit to the first episode of wheeze
  • Patients with the diagnosis of bronchiolitis

Exclusion Criteria

  • Chronic lung or heart disease (hemodynamically significant cardiac disease, chronic lung disease / bronchopulmonary dysplasia requiring diuretics or oxygen)
  • Cystic fibrosis, trisomy 21, immunodeficiency / transplant recipient, neuromuscular disease

Outcomes

Primary Outcomes

Length of stay

Time Frame: an average of 5 days

from date of admission to discharge date

Secondary Outcomes

  • transfer to pediatric intensive care unit (PICU)(an average of 3 days)
  • use of mechanical ventilator(an average of 3 days)

Study Sites (1)

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