Conditions: Bronchiolitis
Keywords: Hypertonic saline Bronchiolitis Infants Wheezing Nebulized Bronchodilator
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 227
Healthy volunteers: yes

Brief summary:
The purpose of this study is to determine if nebulized hypertonic saline (or extra salty water mist) helps infants less than 12 months old hospitalized with bronchiolitis (or bad chest colds) get better enough to be discharged from the hospital sooner than those infants given nebulized normal saline (or regular salty water mist).

Detailed description:
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.

Arms:
arm 1: 4mL nebulized 3% sodium chloride every 4 hours until discharge arm 2: 4 mL nebulized 0.9% sodium chloride every 4 hours until discharge

Interventions: intervention 1: 3% sodium chloride intervention 2: 0.9% sodium chloride
Intervention descriptions: intervention 1: 4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge intervention 2: 4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge

Protocol document: