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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
227
4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge
4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge
Children's Hospital at Montefiore
The Bronx, New York, United States
Length of Stay in the Study-LOS--Intention to Treat Analysis
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.
Time frame: Time of first study treatment until time of discharge
Length of Stay in the Study-LOS by Per Protocol Analysis
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.
Time frame: Time of first study treatment until time of discharge
Readmission for Bronchiolitis Within 7 Days of Discharge
Phone call at 7 days to assess for readmission to any hospital
Time frame: within 7 days of hospital discharge
Clinical Worsening
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
Time frame: though hospitalization/time period receiving study treatment, average 2-3 days
Total Adverse Events
Clinical worsening events (defined prior) + 7 day readmissions
Time frame: Time of enrollment in the study through 1 week after hospital discharge
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