MedTrace Logo

Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis

NCT02029040 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2019-01-25

Study results available
· View outcomes & findings →

Summary

This is a randomized, double-blind, controlled trial in the Pediatric Emergency Department. The primary objective is to determine whether nebulized 3% hypertonic saline is more effective than nebulized 0.9% saline in the treatment of bronchiolitis in the emergency department.

Conditions

  • Acute Bronchiolitis

Interventions

DRUG

3% Hypertonic Saline

Within 5-15 minutes following the administration of the study drug, the Respiratory Distress Assessment Instrument (RDAI) score will be reassessed and study interventions are complete. The patient will be observed for one hour in the emergency department (ED). However, further treatments may be started immediately upon discretion of the treating physician. If the patient is discharged home study PI and/or research assistant will call the parents 7 days from the ED visit to check the number of visits to their primary doctor and/or EDs due to same illness.

DRUG

0.9 % normal saline

Within 5-15 minutes following the administration of the study drug, the Respiratory Distress Assessment Instrument (RDAI) score will be reassessed and study interventions are complete. The patient will be observed for one hour in the emergency department (ED). However, further treatments may be started immediately upon discretion of the treating physician. If the patient is discharged home study PI and/or research assistant will call the parents 7 days from the ED visit to check the number of visits to their primary doctor and/or EDs due to same illness.

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Mohamed Badawy, MD · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02029040 on ClinicalTrials.gov