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

Seoul National University

Status and phase: Withdrawn; Phase 4

Conditions: Acute Bronchiolitis

Treatments: Drug: 0.9% saline + oral dexamethasone; Drug: 3% saline + oral placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01660867

Bronchiolitis_1

Details and patient eligibility

About

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.

Full 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

Sex: All

Ages: 3 to 24 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

0.9% saline + oral placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: 0.9% saline + oral dexamethasone

3% saline + oral placebo

Experimental group

Description:

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

Treatment:

Drug: 3% saline + oral placebo

0.9% saline + oral dexamethasone

Active Comparator group

Description:

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

Treatment:

Drug: 0.9% saline + oral dexamethasone