NCT01488448

A Study of Hypertonic Saline for Infants Hospitalized With Bronchiolitis

A Double-Blind, Controlled, Randomized Clinical Trial of Nebulized Hypertonic Saline for Hospitalized Infants With Viral Bronchiolitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 227 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 12 Months
• Healthy volunteers: Accepted

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.

Conditions

• Bronchiolitis

Interventions

Type	Name	Description
DRUG	3% sodium chloride	4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge
DRUG	0.9% sodium chloride	4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-07-01
• Completion: 2015-08-01
• First posted: 2011-12-08
• Last updated: 2017-02-02
• Results posted: 2014-08-22

Locations

1 site across 1 country: United States