CroupPhase 4NCT01664507
The Effect and Safety of Low Dose Nebulized Epinephrine in Croup
A Phase 4 study testing conventional dose epinephrine and low dose epinephrine in people with Croup and Epinephrine, Administration, Inhalation, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Croup, Epinephrine, Administration, Inhalation
- What is being tested?
- conventional dose epinephrine and low dose epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to Aug 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- croup children between 6 month and 5 years old
- Westley croup score between 3 and 11
Who cannot join
- underlying lung or heart disase
- contra indication to dexamethasone
- immune deficient state
- preterm birth
- previous intubation or apnea history
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Jin Hee Lee, Professor, +82-2-2072-4910, gienee74@gmail.com
Jin Hee Lee, Professor
About this study
Official title: The Effect and Safety of Low Dose Nebulized Epinephrine in the Treatment of Croup
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.
- Conditions
- Croup, Epinephrine, Administration, Inhalation
- Being tested
- conventional dose epinephrine, low dose epinephrine
- Keywords
- croup, dose, epinephrine
- Medical subject headings
- Croup, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional dose epinephrineDrug
conventional dose epinephrine : 0.5mg/kg + 0.9% normal saline
low dose epinephrineDrug
low dose epineprhine : 0.1mg/kg + 0.9% normal saline
| Study group | Role | What they receive |
|---|---|---|
| conventional dose epinephrine | Active comparator | L-epinephrine (1:1000) 0.5 mL/kg (maximum 5mL) + normal saline : total 5mL Receives: Drug: conventional dose epinephrine |
| low dose epinephrine | Experimental | L-epinephrine (1:1000) 0.1 mL/kg (maximum 1mL) + normal saline : total 5mL Receives: Drug: low dose epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the difference of Westley croup score between baseline and 30 minutes after neublized treatment
Measured: 30 minutes
Secondary outcomes (7)
the incidence of use of additional neublized treatment
Measured: 30 minutes
Westley croup score
Measured: 30, 60, 90, 120, 180, 240 minutes
the side effect of epinephrine
Hypertension, tachycardia : more than 95th percentile for age Arrythmia Pallor Tremor
Measured: participants will be followed for the duration of ED stay
respiratory rate, oxygen saturation
Measured: 30, 60, 90, 120, 180, 240 minutes
health care utilization- length of stay in emergency department, admission rate, revisit dut to croup symptom
Measured: within 7 days
treatment failure
after additional nebulized epineprhine at 30 minutes, as the croup scrore is higher than baselin, the blinding is cleared.
Measured: 30min after 2nd epinephrine nebulizer
rebound effect
the croup score is the same or over than the base line
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2012 (estimated)
- Study startJan 2016
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CroupStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Hee Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01664507
- Sponsor's protocol ID
- Croup_01
- Status last verified
- Jan 2018
- First submitted
- 3 Aug 2012
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect and Safety of Low Dose Nebulized Epinephrine in the Treatment of Croup
- ClinicalTrials.gov ID
- NCT01664507
- Acronym / sponsor ID
- Croup_01
- Conditions
- Croup, Epinephrine, Administration, Inhalation
- Keywords
- croup, dose, epinephrine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 14 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional dose epinephrine | Active comparator | Drug: conventional dose epinephrineL-epinephrine (1:1000) 0.5 mL/kg (maximum 5mL) + normal saline : total 5mL |
| low dose epinephrine | Experimental | Drug: low dose epinephrineL-epinephrine (1:1000) 0.1 mL/kg (maximum 1mL) + normal saline : total 5mL |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- croup children between 6 month and 5 years old
- Westley croup score between 3 and 11
Key exclusion criteria (5 listed)
- underlying lung or heart disase
- contra indication to dexamethasone
- immune deficient state
- preterm birth
- previous intubation or apnea history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional dose epinephrineconventional dose epinephrine : 0.5mg/kg + 0.9% normal saline | Drug | conventional dose epinephrine |
| low dose epinephrinelow dose epineprhine : 0.1mg/kg + 0.9% normal saline | Drug | low dose epinephrine |
Primary outcome
the difference of Westley croup score between baseline and 30 minutes after neublized treatment
Time frame: 30 minutes
7 secondary outcomes
the incidence of use of additional neublized treatment
Time frame: 30 minutes
Westley croup score
Time frame: 30, 60, 90, 120, 180, 240 minutes
the side effect of epinephrine
Time frame: participants will be followed for the duration of ED stay
respiratory rate, oxygen saturation
Time frame: 30, 60, 90, 120, 180, 240 minutes
health care utilization- length of stay in emergency department, admission rate, revisit dut to croup symptom
Time frame: within 7 days
treatment failure
Time frame: 30min after 2nd epinephrine nebulizer
rebound effect
Time frame: 180 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Derived from this study: PubMed 30878411Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing conventional dose epinephrine and low dose epinephrine in people with Croup and Epinephrine, Administration, Inhalation, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the difference of Westley croup score between baseline and 30 minutes after neublized treatment (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01664507, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2018.