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

NCT ID: NCT01660867

Last Updated: 2018-01-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-12-31

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

Conditions

Acute Bronchiolitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

0.9% saline + oral placebo

nebulized epinephrine + 0.9% saline + placebo =\> epinephrine + 0.9% saline

Group Type: PLACEBO_COMPARATOR

0.9% saline + oral dexamethasone

Intervention Type: DRUG

nebulized epinephrine + 0.9% saline + dexamethasone =\> nebulized epinephrine + 0.9% saline

3% saline + oral placebo

nebulized epinephrine + 3% saline + placebo =\> nebulized epinephrine + 3% saline

Group Type: EXPERIMENTAL

3% saline + oral placebo

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

0.9% saline + oral dexamethasone

Intervention Type: DRUG

nebulized epinephrine + 0.9% saline + dexamethasone =\> nebulized epinephrine + 0.9% saline

Interventions

3% saline + oral placebo

nebulized epinephrine + 3% saline + placebo =\> nebulized epinephrine + 3% saline

Intervention Type: DRUG

0.9% saline + oral dexamethasone

nebulized epinephrine + 0.9% saline + dexamethasone =\> nebulized epinephrine + 0.9% saline

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jin Hee Lee

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

Bronchiolitis_1

Identifier Type: -

Identifier Source: org_study_id