A Study of Hypertonic Saline for Infants Hospitalized With Bronchiolitis

Not Applicable

Completed

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).

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Nebulized Normal Saline	0.9% sodium chloride	4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
Nebulized Hypertonic Saline	3% sodium chloride	4mL nebulized 3% sodium chloride every 4 hours until discharge

Primary Outcome Measures

Name	Time	Method
Length of Stay in the Study-LOS--Intention to Treat Analysis	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 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.

Secondary Outcome Measures

Name	Time	Method
Total Adverse Events	Time of enrollment in the study through 1 week after hospital discharge	Clinical worsening events (defined prior) + 7 day readmissions
Readmission for Bronchiolitis Within 7 Days of Discharge	within 7 days of hospital discharge	Phone call at 7 days to assess for readmission to any hospital
Clinical Worsening	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