A Study of Hypertonic Saline for Infants Hospitalized With Bronchiolitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Montefiore Medical Center
Sponsor:
Information provided by (Responsible Party):
Alyssa Silver, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01488448
First received: December 2, 2011
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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 Intervention
Bronchiolitis
Drug: 3% sodium chloride
Drug: 0.9% sodium chloride

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Length of Hospital Stay [ Time Frame: duration of hospitalization, average 2-3 days, with additional follow-up phone call 1 week after discharge ] [ Designated as safety issue: No ]
    Length of stay will be defined by the duration between the time of decision to admit a patient (from the time a bed is requested) 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:
  • Readmission for bronchiolitis within 30 days of discharge [ Time Frame: within 30 days of hospital discharge ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 252
Study Start Date: November 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nebulized Hypertonic Saline 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 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

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.

  Eligibility

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01488448

Contacts
Contact: Alyssa H Silver, MD 718-741-2304 alysilve@montefiore.org
Contact: Katherine M O'Connor, MD 718-741-2281 koconnor@montefiore.org

Locations
United States, New York
Children's Hospital at Montefiore Recruiting
Bronx, New York, United States, 10467
Contact: Alyssa H Silver, MD    718-741-2304    alysilve@montefiore.org   
Contact: Katherine M O'Connor, MD    718-741-2281    koconnor@montefiore.org   
Principal Investigator: Alyssa H Silver, MD         
Sub-Investigator: Katherine M O'Connor, MD         
Sub-Investigator: Gabriella C Azzarone, MD         
Sub-Investigator: Nora Esteban-Cruciani, MD, MS         
Sub-Investigator: Lindsey Douglas, MD         
Sub-Investigator: Sheila Liewehr, MD         
Sub-Investigator: Joanne Nazif, MD         
Sub-Investigator: Helen Rhim, MD         
Sub-Investigator: Diana Lee, MD         
Sub-Investigator: Susan Villegas, PhD         
Sub-Investigator: Ilir Agalliu, MD, ScD         
Sub-Investigator: Michael Rinke, MD         
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Alyssa H Silver, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

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
Study First Received: December 2, 2011
Last Updated: September 27, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 22, 2014