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Status unknownNCT01664507Updated Jan 9, 2018

The Effect and Safety of Low Dose Nebulized Epinephrine in Croup

A Phase 4 interventional study of conventional dose epinephrine and low dose epinephrine in Croup and Epinephrine, Administration, Inhalation, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 6 Months to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-09.

Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
6 Months to 5 Years
Sex
All
01

Study summary

Croup is common illness presenting emergency department with dyspnea. The main treatment for croup is nebulized L-epinephrine and steroid. The study for the dose of nebulized L-epinephrine is restricted that the study of comparision between racemic epinephrine and L-epinephrine.

The investigators conducted this study to compare the effectiveness of low dose L-epinephrine with conventional dose L-epinephrine.

02

Conditions studied

  • Croup
  • Epinephrine, Administration, Inhalation

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Keywords

  • croup, dose, epinephrine
03

In context

Croup

18 studies on the registry are indexed under Croup; 2 are open to participants now.

This study's planned enrollment of 84 is close to the median of 86 across 12 interventional studies indexed under Croup.

Browse Croup studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • croup children between 6 month and 5 years old
  • Westley croup score between 3 and 11

Exclusion criteria

Exclusion Criteria:

  • underlying lung or heart disase
  • contra indication to dexamethasone
  • immune deficient state
  • preterm birth
  • previous intubation or apnea history
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
84 participants (estimated)

Study arms

  • Active comparator
    conventional dose epinephrine

    L-epinephrine (1:1000) 0.5 mL/kg (maximum 5mL) + normal saline : total 5mL

    Drug: conventional dose epinephrine

  • Experimental
    low dose epinephrine

    L-epinephrine (1:1000) 0.1 mL/kg (maximum 1mL) + normal saline : total 5mL

    Drug: low dose epinephrine

Interventions

  • Drugconventional dose epinephrine

    conventional dose epinephrine : 0.5mg/kg + 0.9% normal saline

  • low dose epineprhine : 0.1mg/kg + 0.9% normal saline

06

What researchers measure

Primary outcomes

  1. the difference of Westley croup score between baseline and 30 minutes after neublized treatment

    Time frame: 30 minutes

Secondary outcomes

  1. the incidence of use of additional neublized treatment

    Time frame: 30 minutes

  2. Westley croup score

    Time frame: 30, 60, 90, 120, 180, 240 minutes

  3. the side effect of epinephrine

    Hypertension, tachycardia : more than 95th percentile for age Arrythmia Pallor Tremor

    Time frame: participants will be followed for the duration of ED stay

  4. respiratory rate, oxygen saturation

    Time frame: 30, 60, 90, 120, 180, 240 minutes

  5. health care utilization- length of stay in emergency department, admission rate, revisit dut to croup symptom

    Time frame: within 7 days

  6. treatment failure

    after additional nebulized epineprhine at 30 minutes, as the croup scrore is higher than baselin, the blinding is cleared.

    Time frame: 30min after 2nd epinephrine nebulizer

  7. rebound effect

    the croup score is the same or over than the base line

    Time frame: 180 minutes

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
    Recruiting
    • Jin Hee Lee, Professor · Contactgienee74@gmail.com · +82-2-2072-4910
    • Jin Hee Lee, Professor · Principal investigator
    • Hyuksool kwon, Professor · Principal investigator
08

References and documents

Publications

  • Lee JH, Jung JY, Lee HJ, Kim DK, Kwak YH, Chang I, Kwon H, Choi YJ, Park JW, Paek SH, Cho JH. Efficacy of low-dose nebulized epinephrine as treatment for croup: A randomized, placebo-controlled, double-blind trial. Am J Emerg Med. 2019 Dec;37(12):2171-2176. doi: 10.1016/j.ajem.2019.03.012. Epub 2019 Mar 8. PubMed 30878411 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01664507
Responsible party
Jin Hee Lee (Assistant Professor, Seoul National University Hospital) — Principal investigator
First posted
Aug 14, 2012
Start date
Jan 2016
Primary completion
Aug 2018 (estimated)
Completion
Aug 2018 (estimated)
Last update
Jan 9, 2018

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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