A Study of Hypertonic Saline for Infants Hospitalized With Bronchiolitis

Completed 227 enrolled Montefiore Medical Center

RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start: 2011-11
Primary completion: 2014-07
Completion: 2015-08

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Hypertonic Saline vs Normal Saline; p = 0.73; Wilcoxon (Mann-Whitney) NCT01488448 ↗

paper We confirmed findings with per-protocol analysis, HS and NS groups with 2.0 (1.3-3.3) and 2.0 days (1.2-3.0), respectively, P = .96. PMID 26553190 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	sodium chloride	Unknown	3 %	Other