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

Seoul National University Hospital

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Acute Bronchiolitis

Interventions

3% saline + oral placeboDRUG

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

0.9% saline + oral dexamethasoneDRUG

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

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 24 Months

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

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)

Time frame: within 7 days

Secondary Outcomes

RDAI score

Time frame: baseline, between nebulizer, 60min, 120min, 180min, 240min

respiratory rate

Time frame: baseline, between nebulizer, 60min, 120min, 180min, 240min

Heart rate

Time frame: baseline, between nebulizer, 60min, 120min, 180min, 240min

Oxygen saturation

Time frame: baseline, between nebulizer, 60min, 120min, 180min, 240min

unplanned revisit and admission rate after revisit

unplanned revisit admission rate after revisit

Time frame: in 7days

Data from ClinicalTrials.gov

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