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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01660867
Other study ID # Bronchiolitis_1
Secondary ID
Status Withdrawn
Phase Phase 4
First received August 3, 2012
Last updated January 6, 2018
Start date August 2012
Est. completion date December 2014

Study information

Verified date January 2018
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group 3 Months to 24 Months
Eligibility Inclusion Criteria:

- 3mo ~ 24mo aged patients with bronchiolitis visit to emergency departments

- RDAI score 4-15

Exclusion Criteria:

- < 3mo, > 24mo

- infants who had received oral or inhaled corticosteroids during the preceding 2 weeks

- infants with a previous episode of wheezing or a diagnosis of asthma

- any chronic cardiopulmonary disease

- immunodeficiency

- infants needed intubation

- infants with a previous history of apnea or intubation

- infants with side effect of dexamethasone

- infants born at less than 37 weeks of gestation who had a corrected age of less than 6 weeks at presentation

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
3% saline + oral placebo
nebulized epinephrine + 3% saline + placebo => nebulized epinephrine + 3% saline
0.9% saline + oral dexamethasone
nebulized epinephrine + 0.9% saline + dexamethasone => nebulized epinephrine + 0.9% saline

Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary hospital admission within 7 days after the day of enrollment hospital admission within 7 days after the day of enrollment(the initial visit to the emergency department) within 7 days
Secondary RDAI score RDAI score baseline, between nebulizer, 60min, 120min, 180min, 240min
Secondary respiratory rate respiratory rate baseline, between nebulizer, 60min, 120min, 180min, 240min
Secondary Heart rate Heart rate baseline, between nebulizer, 60min, 120min, 180min, 240min
Secondary Oxygen saturation Oxygen saturation baseline, between nebulizer, 60min, 120min, 180min, 240min
Secondary unplanned revisit and admission rate after revisit unplanned revisit admission rate after revisit in 7days
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