Mode
Home
Research
Clinical Trials Drug Pipeline Weekly Digests
Reference
Conditions Medications
Community
Questions
Text Size
Log in / Sign up
N/A N=227 Randomized Quadruple-blind Treatment

A Study of Hypertonic Saline for Infants Hospitalized With Bronchiolitis

Bronchiolitis

Bottom Line

View on ClinicalTrials.gov: NCT01488448 ↗
Enrolled (actual)
227
Serious AEs
10.1%
Results posted
Aug 2014
Primary outcome: Primary: Length of Stay in the Study-LOS--Intention to Treat Analysis — 2.1; 2.1 Days — p=0.73

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
3% sodium chloride (Drug); 0.9% sodium chloride (Drug)
Age
Pediatric
Sex
All
Sponsor
Montefiore Medical Center
Primary completion
Jul 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Length of Stay in the Study-LOS--Intention to Treat Analysis		 2.1; 2.1 0.73
PRIMARY
Length of Stay in the Study-LOS by Per Protocol Analysis		 2.0; 2.0 0.96
SECONDARY
Readmission for Bronchiolitis Within 7 Days of Discharge		 4; 3 0.77
SECONDARY
Clinical Worsening		 10; 9 0.97
SECONDARY
Total Adverse Events		 14; 12 0.67

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).

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01488448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search