Normal Saline vs Hypertonic Saline in the Treatment of Bronchiolitis

Length of Hospital Stay Clinical Trial

Official title:

Normal Saline Versus Hypertonic Saline in the Treatment of Bronchiolitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03143231
• Other study ID #: 1682016
• 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
• 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

Related Conditions & MeSH terms

• Bronchiolitis
• Length of Hospital Stay

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