Clinical trial NCT00619918: Nebulized Hypertonic Saline for Bronchiolitis
Official title: Nebulized Hypertonic Saline for Treatment of Viral Bronchiolitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Bronchiolitis
Keywords: bronchiolitis
hypertonic saline
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
Collaborators: name: UCSF Benioff Children's Hospital Oakland
name: Thrasher Research Fund
First posted: 2008-02-21
Enrollment: 447
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Admission Rate
timeFrame: 1 day
measure: Length of Stay
timeFrame: 1 month
measure: Change in RDAI Score
timeFrame: 1 Hour
Secondary outcomes:
measure: Hours of Oxygen Use
timeFrame: 14 days
measure: IV Fluid Use
timeFrame: 14 days
measure: Number of Participants With Supplemental Medication Use
timeFrame: 14 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Childrens Hospital Los Angeles
state: California
city: Oakland
country: United States
facility: Children's Hospital & Research Center at Oakland
state: California
Study officials:
affiliation: Childrens Hospital Los Angeles/University of Southern California
name: Susan Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.