- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03143231
Normal Saline vs Hypertonic Saline in the Treatment of Bronchiolitis
Normal Saline Versus Hypertonic Saline in the Treatment of Bronchiolitis
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Beirut, Lebanon
- Makassed General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Normal saline
Sodium Chloride 0.9% will be provided
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of stay
Time Frame: an average of 5 days
|
from date of admission to discharge date
|
an average of 5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
transfer to pediatric intensive care unit (PICU)
Time Frame: an average of 3 days
|
admission to PICU
|
an average of 3 days
|
use of mechanical ventilator
Time Frame: an average of 3 days
|
clinical worsening of patients requiring mechanical ventilator
|
an average of 3 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mariam Rajab, MD, Makassed General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1682016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Length of Hospital Stay
-
Ain Shams UniversityRecruiting
-
Ochsner Health SystemCompletedHospital Length of Stay; Adverse Events
-
Far Eastern Memorial HospitalCompletedMechanical Ventilation | Hospital Length of Stay | Minimally Invasive Cardiac SurgeryTaiwan
-
Mayo ClinicEnrolling by invitationHospital Admission | Length of StayUnited States
-
Jie He, MDCompleted
-
Jewish General HospitalActive, not recruitingElderly Care | Multimorbidity | Length of Hospital StayCanada
-
Centre Hospitalier Universitaire, AmiensCompletedArthroplasty | Length of StayFrance
-
Azienda Ospedaliero-Universitaria di ParmaRegione Emilia-RomagnaCompletedHospitalization | Length of StayItaly
-
Gazi UniversityEuropean Society for Emergency Medicine (EUSEM) Research NetworkUnknownEmergencies | Geriatric Patients | Length of Stay | Early Warning Score | Hospital MortalityTurkey, France, Croatia, Germany, Greece, Ireland
Clinical Trials on Normal saline
-
Texas Cardiac Arrhythmia Research FoundationSuspendedVentricular ArrythmiaUnited States
-
The Catholic University of KoreaCompleted
-
Texas Cardiac Arrhythmia Research FoundationCompleted
-
Ann & Robert H Lurie Children's Hospital of ChicagoWithdrawn
-
MemorialCare Health SystemCompletedLength of Labor | Second Stage of Labor | Intravenous Hydration of LaborUnited States
-
University of HaifaWestern Galilee Hospital-NahariyaRecruiting
-
McMaster UniversityGlaxoSmithKline; University of ManchesterRecruitingAsthma | Eosinophilic Bronchitis | Chronic CoughCanada
-
University of MichiganRadiological Society of North AmericaTerminated
-
Virginia Commonwealth UniversityUnited States Department of DefenseWithdrawn
-
Qassim UniversityCompletedApical Periodontitis | Post Operative Pain | Dental Pulp NecrosesSaudi Arabia