Normal Saline vs Hypertonic Saline in the Treatment of Bronchiolitis

Not Applicable

Completed

• Conditions: Length of Hospital Stay
• Interventions: Other: Hypertonic saline; Other: Normal saline

• Registration Number: NCT03143231
• Lead Sponsor: Makassed General Hospital

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.

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2017-04-21
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-08
• Primary Completion: 2017-05-30
• Study Completion: 2017-05-31
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-09
• Last Update Posted: 2017-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypertonic saline	Hypertonic saline	500 ml Sodium Chloride 0.9% with 60 ml Sodium Chloride 20% will be provided
Normal saline	Normal saline	Sodium Chloride 0.9% will be provided

Primary Outcome Measures

Name	Time	Method
Length of stay	an average of 5 days	from date of admission to discharge date

Secondary Outcome Measures

Name	Time	Method
transfer to pediatric intensive care unit (PICU)	an average of 3 days	admission to PICU
use of mechanical ventilator	an average of 3 days	clinical worsening of patients requiring mechanical ventilator

Trial Locations

Locations (1)

Makassed General Hospital; 🇱🇧 Beirut, Lebanon