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

December 2, 2011
December 8, 2011
August 7, 2014
August 22, 2014
February 2, 2017
November 2011
July 2014   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
Length of Hospital Stay [ Time Frame: duration of hospitalization, average 2-3 days, with additional follow-up phone call 1 week after discharge ]
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.
Complete list of historical versions of study NCT01488448 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • 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
Readmission for Bronchiolitis Within 30 Days of Discharge [ Time Frame: within 30 days of hospital discharge ]
Not Provided
Not Provided
 
A Study of Hypertonic Saline for Infants Hospitalized With Bronchiolitis
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).
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Bronchiolitis
  • Drug: 3% sodium chloride
    4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge
    Other Names:
    • hypertonic saline
    • HS
  • 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
  • Experimental: Nebulized Hypertonic Saline
    4mL nebulized 3% sodium chloride every 4 hours until discharge
    Intervention: Drug: 3% sodium chloride
  • Placebo Comparator: Nebulized Normal Saline
    4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
    Intervention: Drug: 0.9% sodium chloride
Silver AH, Esteban-Cruciani N, Azzarone G, Douglas LC, Lee DS, Liewehr S, Nazif JM, Agalliu I, Villegas S, Rhim HJ, Rinke ML, O'Connor K. 3% Hypertonic Saline Versus Normal Saline in Inpatient Bronchiolitis: A Randomized Controlled Trial. Pediatrics. 2015 Dec;136(6):1036-43. doi: 10.1542/peds.2015-1037. Epub 2015 Nov 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
227
232
August 2015
July 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 12 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01488448
11-09-329
Yes
Not Provided
Not Provided
Alyssa Silver, Montefiore Medical Center
Montefiore Medical Center
Not Provided
Principal Investigator: Alyssa H Silver, MD Albert Einstein College of Medicine, Inc.
Montefiore Medical Center
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP