Nebulized Hypertonic Saline for Bronchiolitis

Phase 2

Completed

• Conditions: Bronchiolitis
• Interventions: Drug: Nebulized 3% saline; Drug: Nebulized 0.9% saline

• Registration Number: NCT00619918
• Lead Sponsor: Children's Hospital Los Angeles

Brief Summary

This study aims to examine the effect of nebulized 3% hypertonic saline in the treatment of viral bronchiolitis. The investigators hypothesize that nebulized 3% saline will decrease rate of hospital admission, decrease clinical severity scores, and decrease length of stay.

Detailed Description

Bronchiolitis is the most common viral respiratory infection in young children and infants. It is responsible for hundreds of thousands of outpatient visits and hospitalizations every year. Hypertonic saline may decrease swelling in the lung tissue, improve the patient's ability to clear secretions, and decrease nasal congestion. Hypertonic saline nebulizations have already been used effectively in patients with cystic fibrosis and in a few small trials on infants with bronchiolitis. Patients who come to the emergency department or inpatient ward of two urban free-standing pediatric hospitals in California between December and April and are diagnosed with bronchiolitis will be randomized into two groups- the control group will receive nebulized 0.9% normal saline, while the study group will receive nebulized 3% hypertonic saline. Nebulizations will be pretreated with albuterol, to prevent the theoretical risk of increased wheezing in patients with undiagnosed underlying asthma. Patients will be given up to 3 nebulizations in the emergency department, after which time the attending physician will decide whether admission to the hospital is required. Patients who are admitted will continue to receive the same nebulized treatment every 8 hours until discharged. Additional interventions such as epinephrine treatments and antibiotics can be ordered as indicated by the patient care team.

Investigators will measure symptom severity before and after treatments using the respiratory distress assessment instrument (RDAI). The investigators will compare rates of being admitted to the hospital in each group. The investigators will also compare RDAI scores, average length of stay, number of additional respiratory treatments needed, number of hours requiring oxygen, amount of IV fluid needed, and frequency of adverse effects. The investigators hypothesize that nebulized hypertonic saline will be a safe, cost-effective, and efficacious therapy which can be utilized in the outpatient setting to prevent hospital admission, as well as decrease length of stay for patients who require admission. Given the significant disease burden of viral bronchiolitis, the potential impact is substantial.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-08
• Study First Submitted QC: 2008-02-08
• Study First Posted: 2008-02-21
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Results First Submitted: 2013-07-29
• Results First Submitted QC: 2013-07-29
• Results First Posted: 2013-10-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 447

Inclusion Criteria

• clinical diagnosis of viral bronchiolitis
• between November and April

Exclusion Criteria

• prematurity < 34 weeks
• chronic lung disease
• congenital heart disease
• history of wheezing, asthma or albuterol use
• tracheostomy status
• need for intensive care of assisted ventilation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nebulized 3% Saline	Nebulized 3% saline	3% NaCl, 4 mL inhalation, up to 3 inhalations every 20 minutes in the ED, and Q8H in the inpatient setting.
Nebulized 0.9% Saline	Nebulized 0.9% saline	0.9% NaCl, 4 mL inhalation, up to 3 inhalations every 20 minutes in the ED, and Q8H in the inpatient setting.

Primary Outcome Measures

Name	Time	Method
Admission Rate	1 day	Patients enrolled in the ED who required inpatient admission. Patients who required admission but were transferred to another facility due to lack of available beds were considered admitted for this outcome. Note, neither study site has an observation unit.
Length of Stay	1 month	Length of stay defined as date of discharge minus date of admission (whole days)
Change in RDAI Score	1 Hour	The Respiratory Distress Assessment Instrument (RDAI) is a respiratory severity score ranging from a low score of 0 to maximum score of 17. Lower scores indicate more mild symptoms; mild disease (0-6), moderate disease (7-11), and severe (12-17). A decrease in score of 2 is considered clinically significant improvement.

Secondary Outcome Measures

Name	Time	Method
Hours of Oxygen Use	14 days	Hours requiring supplemental oxygen for admitted patients.
IV Fluid Use	14 days	IV fluid volume administered during entire hospitalization, in mL/kg
Number of Participants With Supplemental Medication Use	14 days	patients who received supplemental albuterol, ipratropium, or epinephrine inhaled treatment (other than pre-treatment for study med)

Trial Locations

Locations (2)

Children's Hospital & Research Center at Oakland; 🇺🇸 Oakland, California, United States

Childrens Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States