Clinical trial NCT03143231: 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
Overall status: COMPLETED
Phase: NA
Conditions: Length of Hospital Stay
Lead sponsor: Makassed General Hospital
Sponsor class: OTHER
First posted: 2017-05-08
Enrollment: 128
Sex: ALL
Minimum age (years): 15
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Length of stay
timeFrame: an average of 5 days
Secondary outcomes:
measure: transfer to pediatric intensive care unit (PICU)
timeFrame: an average of 3 days
measure: use of mechanical ventilator
timeFrame: an average of 3 days
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Makassed General Hospital
Study officials:
affiliation: Makassed General Hospital
name: Mariam Rajab, MD
role: PRINCIPAL_INVESTIGATOR
References: