A Study of Hypertonic Saline for Infants Hospitalized With Bronchiolitis

January 31, 2017 updated by: Alyssa Silver, Montefiore Medical Center

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

227

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10467
        • Children's Hospital at Montefiore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nebulized Hypertonic Saline
4mL nebulized 3% sodium chloride every 4 hours until discharge
Drug: 3% sodium chloride
4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge
Other Names:
  • HS
  • hypertonic saline
Placebo Comparator: Nebulized Normal Saline
4 mL nebulized 0.9% sodium chloride 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
Other Names:
  • normal saline
  • NS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Stay in the Study-LOS--Intention to Treat Analysis
Time Frame: Time of first study treatment until time of discharge
Length of stay will be defined by the duration between the time of first study treatment to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used.
Time of first study treatment until time of discharge
Length of Stay in the Study-LOS by Per Protocol Analysis
Time Frame: Time of first study treatment until time of discharge
Length of stay will be defined by the duration between the time of first study treatment to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used.
Time of first study treatment until time of discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission for Bronchiolitis Within 7 Days of Discharge
Time Frame: within 7 days of hospital discharge
Phone call at 7 days to assess for readmission to any hospital
within 7 days of hospital discharge
Clinical Worsening
Time Frame: though hospitalization/time period receiving study treatment, average 2-3 days
transfer to the Pediatric Intensive Care Unit (PICU) (including withdrawn from the study for bronchodilator administration who were then transferred to the PICU), or Respiratory Distress Assessment Instrument (RDAI) increase of 4 or more points within 30 minutes of a study treatment
though hospitalization/time period receiving study treatment, average 2-3 days
Total Adverse Events
Time Frame: Time of enrollment in the study through 1 week after hospital discharge
Clinical worsening events (defined prior) + 7 day readmissions
Time of enrollment in the study through 1 week after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Alyssa H Silver, MD, Albert Einstein College Of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

December 2, 2011

First Submitted That Met QC Criteria

December 6, 2011

First Posted (Estimate)

December 8, 2011

Study Record Updates

Last Update Posted (Estimate)

February 2, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-09-329

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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