Nebulized Hypertonic Saline for Bronchiolitis

Bronchiolitis Clinical Trial

Official title:

Nebulized Hypertonic Saline for Treatment of Viral Bronchiolitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00619918
• Other study ID #: CCI-06-00271
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 8, 2008
• Last updated: July 29, 2013
• Start date: February 2008
• Est. completion date: May 2011

Study information

• Verified date: July 2013
• Source: Children's Hospital Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 447
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Drug:
• Nebulized 3% saline
4 ml inhaled q8h
• Placebo
normal saline

Locations

Country	Name	City	State
United States	Childrens Hospital Los Angeles	Los Angeles	California
United States	Children's Hospital & Research Center at Oakland	Oakland	California

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles	Children's Hospital & Research Center Oakland, Thrasher Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Length of Stay	Length of stay defined as date of discharge minute date of admission.	1 month	No
Primary	Change in RDAI Score		1 day	No
Secondary	Hours of Oxygen Use		14 days	No
Secondary	IV Fluid Use		14 days	No
Secondary	Supplemental Medication Use		14 days	No