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Normal Saline vs Hypertonic Saline in the Treatment of Bronchiolitis

NCT03143231 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2017-06-12

No results posted yet for this study

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.

Conditions

  • Length of Hospital Stay

Interventions

OTHER

Normal saline

The normal saline will be divided in 3ml aliquots that will be preserved in the pharmacy refrigerator between 2 and 60\[0\]C. Once a patient had been randomized, 6 aliquots would be prepared daily until the end of the trial.

OTHER

Hypertonic saline

The mixture (500 ml Sodium Chloride 0.9% with 60 ml Sodium chloride 20%) will be divided in 3ml aliquots that will be preserved in the pharmacy refrigerator between 2 and 60\[0\]C. Once a patient had been randomized, 6 aliquots would be prepared daily until the end of the trial.

Sponsors & Collaborators

  • Makassed General Hospital

    lead OTHER

Principal Investigators

  • Mariam Rajab, MD · Makassed General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Days
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2017-05-30
Completion
2017-05-31

Countries

  • Lebanon

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03143231 on ClinicalTrials.gov