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

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.

Study Overview

• Status: Withdrawn
• Conditions: Acute Bronchiolitis
• Intervention / Treatment: Drug: 0.9% saline + oral dexamethasone; Drug: 3% saline + oral placebo

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

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 2 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 0.9% saline + oral placebo; nebulized epinephrine + 0.9% saline + placebo => epinephrine + 0.9% saline	Drug: 0.9% saline + oral dexamethasone; nebulized epinephrine + 0.9% saline + dexamethasone => nebulized epinephrine + 0.9% saline
EXPERIMENTAL: 3% saline + oral placebo; nebulized epinephrine + 3% saline + placebo => nebulized epinephrine + 3% saline	Drug: 3% saline + oral placebo; nebulized epinephrine + 3% saline + placebo => nebulized epinephrine + 3% saline
ACTIVE_COMPARATOR: 0.9% saline + oral dexamethasone; nebulized epinephrine + 0.9% saline + dexamethasone => nebulized epinephrine + 0.9% saline	Drug: 0.9% saline + oral dexamethasone; nebulized epinephrine + 0.9% saline + dexamethasone => nebulized epinephrine + 0.9% saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: August 3, 2012
• First Submitted That Met QC Criteria: August 8, 2012
• First Posted (ESTIMATE): August 9, 2012

Study Record Updates

• Last Update Posted (ACTUAL): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 6, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: hospital admission within 7 days of 3% NaCl nebulizer vs dexamethasone
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Emergencies; Bronchiolitis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: Bronchiolitis_1