NCT02029040

Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis

A Randomized Trial of Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in The Emergency Department

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 2 Months – 12 Months
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-01-07
• Last updated: 2019-01-25
• Results posted: 2019-01-25

Locations

1 site across 1 country: United States