A Study of Hypertonic Saline for Infants Hospitalized With Bronchiolitis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alyssa Silver, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01488448
First received: December 2, 2011
Last updated: September 18, 2014
Last verified: September 2014
  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 Stay in the Study-LOS [ Time Frame: Time of first study treatment until time of discharge ] [ Designated as safety issue: No ]
    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:
  • Readmission for Bronchiolitis Within 30 Days of Discharge [ Time Frame: within 30 days of hospital discharge ] [ Designated as safety issue: Yes ]

Enrollment: 227
Study Start Date: November 2011
Estimated Study Completion Date: July 2015
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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 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
Results First Received: August 7, 2014
Last Updated: September 18, 2014
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
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 01, 2014