Nebulized 3% saline
Drug4 ml inhaled q8h
Other names: 3% saline, Hypertonic saline, NaCl 3%
NCT Number: NCT00619918
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.
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All sexes
Interventional
Phase 2 / Phase 3
Childrens Hospital Los Angeles, Los Angeles, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
4 ml inhaled q8h
Other names: 3% saline, Hypertonic saline, NaCl 3%
normal saline
Other names: Normal saline, NS, NaCl 0.9%
Time frame: 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.
Time frame: 1 month
Length of stay defined as date of discharge minus date of admission (whole days)
Time frame: 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.
Time frame: 14 days
Hours requiring supplemental oxygen for admitted patients.
Time frame: 14 days
IV fluid volume administered during entire hospitalization, in mL/kg
Time frame: 14 days
patients who received supplemental albuterol, ipratropium, or epinephrine inhaled treatment (other than pre-treatment for study med)
Children's Hospital Los Angeles
Other
Nebulized Hypertonic Saline for Treatment of Viral Bronchiolitis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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