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Normal Saline vs Hypertonic Saline in the Treatment of Bronchiolitis

Primary Purpose

Length of Hospital Stay

Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Normal saline
Hypertonic saline
Sponsored by
Makassed General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Length of Hospital Stay

Eligibility Criteria

15 Days - 2 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Makassed General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Normal saline

Hypertonic saline

Arm Description

Sodium Chloride 0.9% will be provided

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

Outcomes

Primary Outcome Measures

Length of stay
from date of admission to discharge date

Secondary Outcome Measures

transfer to pediatric intensive care unit (PICU)
admission to PICU
use of mechanical ventilator
clinical worsening of patients requiring mechanical ventilator

Full Information

First Posted
April 21, 2017
Last Updated
June 9, 2017
Sponsor
Makassed General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03143231
Brief Title
Normal Saline vs Hypertonic Saline in the Treatment of Bronchiolitis
Official Title
Normal Saline Versus Hypertonic Saline in the Treatment of Bronchiolitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
May 30, 2017 (Actual)
Study Completion Date
May 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Makassed General Hospital

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Length of Hospital Stay

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal saline
Arm Type
Experimental
Arm Description
Sodium Chloride 0.9% will be provided
Arm Title
Hypertonic saline
Arm Type
Experimental
Arm Description
500 ml Sodium Chloride 0.9% with 60 ml Sodium Chloride 20% will be provided
Intervention Type
Other
Intervention Name(s)
Normal saline
Intervention Description
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
Intervention Name(s)
Hypertonic saline
Intervention Description
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 Measure Information:
Title
Length of stay
Description
from date of admission to discharge date
Time Frame
an average of 5 days
Secondary Outcome Measure Information:
Title
transfer to pediatric intensive care unit (PICU)
Description
admission to PICU
Time Frame
an average of 3 days
Title
use of mechanical ventilator
Description
clinical worsening of patients requiring mechanical ventilator
Time Frame
an average of 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Days
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariam Rajab, MD
Organizational Affiliation
Makassed General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Makassed General Hospital
City
Beirut
Country
Lebanon

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Normal Saline vs Hypertonic Saline in the Treatment of Bronchiolitis

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