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
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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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 60C. 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 60C. Once a patient had been randomized, 6 aliquots would be prepared daily until the end of the trial.
- Length of stay [ Time Frame: an average of 5 days ]from date of admission to discharge date
- transfer to pediatric intensive care unit (PICU) [ Time Frame: an average of 3 days ]admission to PICU
- use of mechanical ventilator [ Time Frame: an average of 3 days ]clinical worsening of patients requiring mechanical ventilator
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03143231
|Makassed General Hospital|
|Principal Investigator:||Mariam Rajab, MD||Makassed General Hospital|