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

Phase 4

Withdrawn

• Conditions: Acute Bronchiolitis
• Interventions: Drug: 0.9% saline + oral dexamethasone; Drug: 3% saline + oral placebo

• Registration Number: NCT01660867
• Lead Sponsor: Seoul National University Hospital

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.

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-03
• Study First Submitted QC: 2012-08-08
• Study First Posted: 2012-08-09
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-06
• Last Update Posted: 2018-01-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 3mo ~ 24mo aged patients with bronchiolitis visit to emergency departments
• RDAI score 4-15

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.9% saline + oral dexamethasone	0.9% saline + oral dexamethasone	nebulized epinephrine + 0.9% saline + dexamethasone =\> nebulized epinephrine + 0.9% saline
0.9% saline + oral placebo	0.9% saline + oral dexamethasone	nebulized epinephrine + 0.9% saline + placebo =\> epinephrine + 0.9% saline
3% saline + oral placebo	3% saline + oral placebo	nebulized epinephrine + 3% saline + placebo =\> nebulized epinephrine + 3% saline

Primary Outcome Measures

Name	Time	Method
hospital admission within 7 days after the day of enrollment	within 7 days	hospital admission within 7 days after the day of enrollment(the initial visit to the emergency department)

Secondary Outcome Measures

Name	Time	Method
Heart rate	baseline, between nebulizer, 60min, 120min, 180min, 240min	Heart rate
RDAI score	baseline, between nebulizer, 60min, 120min, 180min, 240min	RDAI score
respiratory rate	baseline, between nebulizer, 60min, 120min, 180min, 240min	respiratory rate
Oxygen saturation	baseline, between nebulizer, 60min, 120min, 180min, 240min	Oxygen saturation
unplanned revisit and admission rate after revisit	in 7days	unplanned revisit admission rate after revisit

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of