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Normal Saline vs Hypertonic Saline in the Treatment of Bronchiolitis

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ClinicalTrials.gov Identifier: NCT03143231
Recruitment Status : Completed
First Posted : May 8, 2017
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
Mariam Rajab, 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.


Condition or disease Intervention/treatment Phase
Length of Hospital Stay Other: Normal saline Other: Hypertonic saline Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Normal Saline Versus Hypertonic Saline in the Treatment of Bronchiolitis
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : May 30, 2017
Actual Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Normal saline
Sodium Chloride 0.9% will be provided
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.

Experimental: Hypertonic saline
500 ml Sodium Chloride 0.9% with 60 ml Sodium Chloride 20% will be provided
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.




Primary Outcome Measures :
  1. Length of stay [ Time Frame: an average of 5 days ]
    from date of admission to discharge date


Secondary Outcome Measures :
  1. transfer to pediatric intensive care unit (PICU) [ Time Frame: an average of 3 days ]
    admission to PICU

  2. use of mechanical ventilator [ Time Frame: an average of 3 days ]
    clinical worsening of patients requiring mechanical ventilator



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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03143231


Locations
Lebanon
Makassed General Hospital
Beirut, Lebanon
Sponsors and Collaborators
Makassed General Hospital
Investigators
Principal Investigator: Mariam Rajab, MD Makassed General Hospital

Responsible Party: Mariam Rajab, Chairperson of pediatrics department, Makassed General Hospital
ClinicalTrials.gov Identifier: NCT03143231     History of Changes
Other Study ID Numbers: 1682016
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections