Normal Saline vs Hypertonic Saline in the Treatment of Bronchiolitis

NCT03143231 | Completed

• 1 other identifier: 1682016
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Length of Hospital Stay

Outcome Measures

Primary Outcomes (1)

• Length of stay

  from date of admission to discharge date

  an average of 5 days

Secondary Outcomes (2)

• transfer to pediatric intensive care unit (PICU)

  an average of 3 days

• use of mechanical ventilator

  an average of 3 days

Study Arms (2)

Normal saline

EXPERIMENTAL

Sodium Chloride 0.9% will be provided

Other: Normal saline

Hypertonic saline

EXPERIMENTAL

500 ml Sodium Chloride 0.9% with 60 ml Sodium Chloride 20% will be provided

Other: Hypertonic saline

Interventions

Normal saline OTHER

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.

Normal saline

Hypertonic saline OTHER

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.

Hypertonic saline

Eligibility Criteria

• Age: 15 Days - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Makassed General Hospital: lead

Study Sites (1)

Makassed General Hospital

Beirut, Lebanon

Location

MeSH Terms

Interventions

Saline Solution; Saline Solution, Hypertonic

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Hypertonic Solutions

Study Officials

• Mariam Rajab, MD

  Makassed General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairperson of pediatrics department

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: May 8, 2017
• Study Start: March 1, 2016
• Primary Completion: May 30, 2017
• Study Completion: May 31, 2017
• Last Updated: June 12, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)