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).
Brief Title
A Study of Hypertonic Saline for Infants Hospitalized With Bronchiolitis
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Bronchiolitis
Eligibility 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
* 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
Inclusion Criteria
Inclusion Criteria:
* Patients 0-12 months of age admitted to the hospital with a diagnosis of bronchiolitis.
* Patients 0-12 months of age admitted to the hospital with a diagnosis of bronchiolitis.
Gender
All
Gender Based
false
Keywords
Hypertonic saline
Bronchiolitis
Infants
Wheezing
Nebulized
Bronchodilator
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
12 Months
NCT Id
NCT01488448
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
11-09-329
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Double-Blind, Controlled, Randomized Clinical Trial of Nebulized Hypertonic Saline for Hospitalized Infants With Viral Bronchiolitis
Primary Outcomes
Outcome Description
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.
Outcome Measure
Length of Stay in the Study-LOS--Intention to Treat Analysis
Outcome Time Frame
Time of first study treatment until time of discharge
Outcome Description
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.
Outcome Measure
Length of Stay in the Study-LOS by Per Protocol Analysis
Outcome Time Frame
Time of first study treatment until time of discharge
Secondary Outcomes
Outcome Description
Phone call at 7 days to assess for readmission to any hospital
Outcome Time Frame
within 7 days of hospital discharge
Outcome Measure
Readmission for Bronchiolitis Within 7 Days of Discharge
Outcome Description
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
Outcome Time Frame
though hospitalization/time period receiving study treatment, average 2-3 days
Outcome Measure
Clinical Worsening
Outcome Description
Clinical worsening events (defined prior) + 7 day readmissions
Outcome Time Frame
Time of enrollment in the study through 1 week after hospital discharge
Outcome Measure
Total Adverse Events
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Maximum Age Number (converted to Years and rounded down)
1
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Alyssa Silver
Investigator Email
alysilve@montefiore.org
Investigator Phone
718-741-2304
Categories Mesh Debug
COVID-19 --- RESPIRATORY TRACT INFECTIONS
Lung --- RESPIRATORY TRACT INFECTIONS
COVID-19 --- INFECTIONS
Infectious Disease --- INFECTIONS
Asthma and Other Respiratory Diseases --- BRONCHIAL DISEASES
Lung --- BRONCHIAL DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
Lung & Chest Cancers --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
Lung --- LUNG DISEASES, OBSTRUCTIVE
Lung & Chest Cancers --- LUNG DISEASES
COVID-19 --- LUNG DISEASES
Lung --- LUNG DISEASES
MeSH Terms
BRONCHIOLITIS
RESPIRATORY SOUNDS
BRONCHITIS
RESPIRATORY TRACT INFECTIONS
INFECTIONS
BRONCHIAL DISEASES
RESPIRATORY TRACT DISEASES
LUNG DISEASES, OBSTRUCTIVE
LUNG DISEASES
SIGNS AND SYMPTOMS, RESPIRATORY
SIGNS AND SYMPTOMS
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
SODIUM CHLORIDE
SALINE SOLUTION, HYPERTONIC
SALINE SOLUTION
CHLORIDES
HYDROCHLORIC ACID
CHLORINE COMPOUNDS
INORGANIC CHEMICALS
SODIUM COMPOUNDS
HYPERTONIC SOLUTIONS
SOLUTIONS
PHARMACEUTICAL PREPARATIONS
CRYSTALLOID SOLUTIONS
ISOTONIC SOLUTIONS