Clinical trial NCT01488448: A Study of Hypertonic Saline for Infants Hospitalized With Bronchiolitis
Official title: A Double-Blind, Controlled, Randomized Clinical Trial of Nebulized Hypertonic Saline for Hospitalized Infants With Viral Bronchiolitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Keywords: Hypertonic saline
Bronchiolitis
Infants
Wheezing
Nebulized
Bronchodilator
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2011-12-08
Enrollment: 227
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Length of Stay in the Study-LOS--Intention to Treat Analysis
timeFrame: Time of first study treatment until time of discharge
measure: Length of Stay in the Study-LOS by Per Protocol Analysis
timeFrame: Time of first study treatment until time of discharge
Secondary outcomes:
measure: Readmission for Bronchiolitis Within 7 Days of Discharge
timeFrame: within 7 days of hospital discharge
measure: Clinical Worsening
timeFrame: though hospitalization/time period receiving study treatment, average 2-3 days
measure: Total Adverse Events
timeFrame: Time of enrollment in the study through 1 week after hospital discharge
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Children's Hospital at Montefiore
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Alyssa H Silver, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.