A Study of Hypertonic Saline for Infants Hospitalized With Bronchiolitis

Bronchiolitis is a common admitting diagnosis for children less than 1 year of age. Although
bronchiolitis has a high prevalence, there is a lack of a unified inpatient treatment plan
beyond supportive care of supplemental oxygen and intravenous hydration. There have been
many different approaches to the treatment of bronchiolitis, but none have conclusively
proven to be beneficial. Several early studies show promise for the use of nebulized
hypertonic saline, however the majority of these studies are done outside the United States
and with adjunctive therapy. To date, the data suggesting that nebulized hypertonic saline
is safe and effective for reducing length of stay in bronchiolitis is strong but not
generalizable for the United States. The objective of this study is to conduct the first
double-blind, randomized controlled trial in the United States of nebulized hypertonic
saline without adjunctive therapy, including infants with bronchiolitis, including those
with prior history of wheeze, to assess the effect on length of stay and therefore resource
utilization.

Inclusion Criteria:

- Patients 0-12 months of age admitted to the hospital with a diagnosis of
bronchiolitis.

Exclusion Criteria:

- status asthmaticus

- chronic cardiopulmonary disease

- Trisomy 21

- immunodeficiency or transplant recipient

- neuromuscular disease

- admission directly to the intensive care unit

- previous use of nebulized hypertonic saline less than 12 hours prior to presentation

- previous enrollment in the study in the 72 hours prior to presentation