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

Primary Purpose

Acute Bronchiolitis

Status
Withdrawn
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
3% saline + oral placebo
0.9% saline + oral dexamethasone
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Bronchiolitis focused on measuring hospital admission within 7 days of 3% NaCl nebulizer vs dexamethasone

Eligibility Criteria

3 Months - 24 Months (Child)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

0.9% saline + oral placebo

3% saline + oral placebo

0.9% saline + oral dexamethasone

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

RDAI score
RDAI score
respiratory rate
respiratory rate
Heart rate
Heart rate
Oxygen saturation
Oxygen saturation
unplanned revisit and admission rate after revisit
unplanned revisit admission rate after revisit

Full Information

First Posted
August 3, 2012
Last Updated
January 6, 2018
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01660867
Brief Title
Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in the Emergency Department
Official Title
Nebulized 3% Hypertonic Saline in the Treatment of Acute Bronchiolitis in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Withdrawn
Why Stopped
there was no eligible patients
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bronchiolitis
Keywords
hospital admission within 7 days of 3% NaCl nebulizer vs dexamethasone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.9% saline + oral placebo
Arm Type
Placebo Comparator
Arm Description
nebulized epinephrine + 0.9% saline + placebo => epinephrine + 0.9% saline
Arm Title
3% saline + oral placebo
Arm Type
Experimental
Arm Description
nebulized epinephrine + 3% saline + placebo => nebulized epinephrine + 3% saline
Arm Title
0.9% saline + oral dexamethasone
Arm Type
Active Comparator
Arm Description
nebulized epinephrine + 0.9% saline + dexamethasone => nebulized epinephrine + 0.9% saline
Intervention Type
Drug
Intervention Name(s)
3% saline + oral placebo
Intervention Description
nebulized epinephrine + 3% saline + placebo => nebulized epinephrine + 3% saline
Intervention Type
Drug
Intervention Name(s)
0.9% saline + oral dexamethasone
Intervention Description
nebulized epinephrine + 0.9% saline + dexamethasone => nebulized epinephrine + 0.9% saline
Primary Outcome Measure Information:
Title
hospital admission within 7 days after the day of enrollment
Description
hospital admission within 7 days after the day of enrollment(the initial visit to the emergency department)
Time Frame
within 7 days
Secondary Outcome Measure Information:
Title
RDAI score
Description
RDAI score
Time Frame
baseline, between nebulizer, 60min, 120min, 180min, 240min
Title
respiratory rate
Description
respiratory rate
Time Frame
baseline, between nebulizer, 60min, 120min, 180min, 240min
Title
Heart rate
Description
Heart rate
Time Frame
baseline, between nebulizer, 60min, 120min, 180min, 240min
Title
Oxygen saturation
Description
Oxygen saturation
Time Frame
baseline, between nebulizer, 60min, 120min, 180min, 240min
Title
unplanned revisit and admission rate after revisit
Description
unplanned revisit admission rate after revisit
Time Frame
in 7days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

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

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