Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in the Emergency Department

Acute Bronchiolitis Clinical Trial

Official title:

Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in the Emergency Department

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01660867
• Other study ID #: Bronchiolitis_1
• Status: Withdrawn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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Acute Bronchiolitis
• Bronchiolitis
• Emergencies

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