Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT01660867
Status:
WITHDRAWN
Last Update Posted:
2018-01-09
First Post:
2012-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in the Emergency Department
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in the Emergency Department
Status:
WITHDRAWN
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
there was no eligible patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective, randomized, controlled, double-blinded, clinical trial
Subject : 3mo \~ 24mo. aged infants with bronchiolitis
The effect of 3 % NaCl nebulizer or dexamethasone on admission rate of these infants in ED.
Subject : 3mo \~ 24mo. aged infants with bronchiolitis
The effect of 3 % NaCl nebulizer or dexamethasone on admission rate of these infants in ED.
Detailed Description:
Randomly assigned to one of three groups
* Group I : nebulized epinephrine + 0.9% saline + placebo
* Group II : nebulized epinephrine + 3% saline + placebo
* Group III : nebulized epinephrine + 0.9% saline + dexamethasone
Group I received two treatments of nebulized epinephrine mixed 0.9% saline and a total of six oral doses of placebo, group II received nebulized epinephrine mixed 3% saline and oral placebo, and group III received nebulized epinephrine mixed 0.9% saline and oral dexamethasone.
The primary outcome is hospital admission within 7 days after the day of enrollment
* Group I : nebulized epinephrine + 0.9% saline + placebo
* Group II : nebulized epinephrine + 3% saline + placebo
* Group III : nebulized epinephrine + 0.9% saline + dexamethasone
Group I received two treatments of nebulized epinephrine mixed 0.9% saline and a total of six oral doses of placebo, group II received nebulized epinephrine mixed 3% saline and oral placebo, and group III received nebulized epinephrine mixed 0.9% saline and oral dexamethasone.
The primary outcome is hospital admission within 7 days after the day of enrollment
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: