A Study of Hypertonic Saline for Infants Hospitalized With Bronchiolitis

Montefiore Medicine Academic Health System

Status: Completed

Conditions: Bronchiolitis

Treatments: Drug: 0.9% sodium chloride; Drug: 3% sodium chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT01488448

11-09-329

Details and patient eligibility

About

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).

Full 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.

Enrollment: 227 patients

Sex: All

Ages: Under 12 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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227 participants in 2 patient groups, including a placebo group

Nebulized Hypertonic Saline

Experimental group

Description:

4mL nebulized 3% sodium chloride every 4 hours until discharge

Treatment:

Drug: 3% sodium chloride

Nebulized Normal Saline

Placebo Comparator group

Description:

4 mL nebulized 0.9% sodium chloride every 4 hours until discharge

Treatment:

Drug: 0.9% sodium chloride