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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03143231
Other study ID # 1682016
Secondary ID
Status Completed
Phase N/A
First received April 21, 2017
Last updated June 9, 2017
Start date March 1, 2016
Est. completion date May 31, 2017

Study information

Verified date June 2017
Source Makassed General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 128
Est. completion date May 31, 2017
Est. primary completion date May 30, 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Lebanon Makassed General Hospital Beirut

Sponsors (1)

Lead Sponsor Collaborator
Makassed General Hospital

Country where clinical trial is conducted

Lebanon, 

Outcome

Type Measure Description Time frame Safety issue
Primary Length of stay from date of admission to discharge date an average of 5 days
Secondary transfer to pediatric intensive care unit (PICU) admission to PICU an average of 3 days
Secondary use of mechanical ventilator clinical worsening of patients requiring mechanical ventilator an average of 3 days
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