ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Hypertonic Saline for Infants Hospitalized With Bronchiolitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01488448
Recruitment Status : Completed
First Posted : December 8, 2011
Results First Posted : August 22, 2014
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
Alyssa Silver, Montefiore Medical Center

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).

Condition or disease Intervention/treatment Phase
Bronchiolitis Drug: 3% sodium chloride Drug: 0.9% sodium chloride Not Applicable

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  (Clinical Trial)
Actual Enrollment : 227 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Controlled, Randomized Clinical Trial of Nebulized Hypertonic Saline for Hospitalized Infants With Viral Bronchiolitis
Study Start Date : November 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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:
  • hypertonic saline
  • HS
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



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01488448


Locations
United States, New York
Children's Hospital at Montefiore
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Alyssa H Silver, MD Albert Einstein College of Medicine, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alyssa Silver, Attending Physician, Pediatric Hospitalist, Assistant Professor of Pediatrics, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01488448     History of Changes
Other Study ID Numbers: 11-09-329
First Posted: December 8, 2011    Key Record Dates
Results First Posted: August 22, 2014
Last Update Posted: February 2, 2017
Last Verified: January 2017

Keywords provided by Alyssa Silver, Montefiore Medical Center:
Hypertonic saline
Bronchiolitis
Infants
Wheezing
Nebulized
Bronchodilator

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections