A Study of Hypertonic Saline for Infants Hospitalized With Bronchiolitis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

227 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-08-31

Brief Summary

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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).

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Detailed Description

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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

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Bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nebulized Hypertonic Saline

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

Group Type EXPERIMENTAL

3% sodium chloride

Intervention Type DRUG

4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge

Nebulized Normal Saline

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

Group Type PLACEBO_COMPARATOR

0.9% sodium chloride

Intervention Type DRUG

4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge

Interventions

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3% sodium chloride

4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge

Intervention Type DRUG

0.9% sodium chloride

4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge

Intervention Type DRUG

Other Intervention Names

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hypertonic saline HS normal saline NS

Eligibility Criteria

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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

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes