Normal Saline vs Hypertonic Saline in the Treatment of Bronchiolitis

NCT ID: NCT03143231

Last Updated: 2017-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-01
• Study Completion Date: 2017-05-31

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.

Conditions

Length of Hospital Stay

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Normal saline

Sodium Chloride 0.9% will be provided

Group Type: EXPERIMENTAL

Normal saline

Intervention Type: 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.

Hypertonic saline

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

Group Type: EXPERIMENTAL

Hypertonic saline

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 15 Days
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Makassed General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mariam Rajab

Chairperson of pediatrics department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mariam Rajab, MD

Role: PRINCIPAL_INVESTIGATOR

Makassed General Hospital

Locations

Makassed General Hospital

Beirut, , Lebanon

Countries

Lebanon

Other Identifiers

1682016

Identifier Type: -

Identifier Source: org_study_id