Nebulized Hypertonic Saline for Bronchiolitis

Nebulized Hypertonic Saline for Treatment of Viral Bronchiolitis

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.

Study Overview

• Status: Completed
• Conditions: Bronchiolitis
• Intervention / Treatment: Drug: Nebulized 3% saline; Drug: Nebulized 0.9% saline

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 Type: Interventional
• Enrollment (Actual): 447
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Childrens Hospital Los Angeles
    • Oakland, California, United States, 94609
      • Children'S Hospital & Research Center At Oakland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nebulized 3% Saline; 3% NaCl, 4 mL inhalation, up to 3 inhalations every 20 minutes in the ED, and Q8H in the inpatient setting.	Drug: Nebulized 3% saline; 4 ml inhaled q8h; Other Names: Hypertonic saline; 3% saline; NaCl 3%
Placebo Comparator: 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.	Drug: Nebulized 0.9% saline; normal saline; Other Names: NaCl 0.9%; NS; Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Admission Rate	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.	1 day
Length of Stay	Length of stay defined as date of discharge minus date of admission (whole days)	1 month
Change in RDAI Score	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.	1 Hour

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Collaborators: Thrasher Research Fund; UCSF Benioff Children's Hospital Oakland
• Investigators: Principal Investigator: Susan Wu, MD, Childrens Hospital Los Angeles/University of Southern California

Publications and helpful links

General Publications

• Wu S, Baker C, Lang ME, Schrager SM, Liley FF, Papa C, Mira V, Balkian A, Mason WH. Nebulized hypertonic saline for bronchiolitis: a randomized clinical trial. JAMA Pediatr. 2014 Jul;168(7):657-63. doi: 10.1001/jamapediatrics.2014.301. Erratum In: JAMA Pediatr. 2014 Oct;168(10):971.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: February 8, 2008
• First Submitted That Met QC Criteria: February 8, 2008
• First Posted (Estimated): February 21, 2008

Study Record Updates

• Last Update Posted (Actual): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 1, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: hypertonic saline; bronchiolitis
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: CCI-06-00271

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No