CroupPhase 2NCT00230841
Comparing Different Ways of Delivering Humidity to Children With Croup
A Phase 2 study testing nebulized humidity in people with Croup, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Croup affects 5% of children under 6 years of age, resulting in visits to hospital Emergency Departments, and in 1% of children, hospitalization. Traditionally, the first therapy offered is humidification which can liquify airway secretions and decrease airway swelling. Read more about this study
- Who is it for?
- Ages 3 months to 10 years
- Conditions the study is for
- Croup
- What is being tested?
- nebulized humidity
- Type of treatment
- Medical device
- How many people
- 129 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2001to Apr 2004
- Phase
- Phase 2
- 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 3 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 3 months - 10 years
- croup score greater than or equal to 2 after a 30 minute waiting period
Who cannot join
- Symptoms of croup requiring immediate intervention with nebulized epinephrine or intubation
- symptoms or signs of alternative causes of stridor
- inability of caregivers to understand or speak English and/or sign for informed consent
- history of chronic pulmonary disease except for asthma, or co-existent systemic disease
- previous history of intubation
- duration of present illness >1 week
- systemic or inhaled glucocorticoids in previous 48 hours
- epinephrine in previous 4 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Optimal Versus 'Traditional' Delivery of Humidity in Children With Croup
Croup affects 5% of children under 6 years of age, resulting in visits to hospital Emergency Departments, and in 1% of children, hospitalization. Traditionally, the first therapy offered is humidification which can liquify airway secretions and decrease airway swelling. This study will compare the effectivenesss of 40% and 100% humidity through a specially designed machine called a nebulizer, with the usual humidity set-up (blown into the patient's face from a hose).
- Conditions
- Croup
- Being tested
- nebulized humidity
- Keywords
- croup, humidity therapy, pediatrics
- Medical subject headings
- Croup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nebulized humidityDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in the croup score from baseline to 30 and 60 minutes
Secondary outcomes (3)
steroid or epinephrine treatment at 60 minutes
discharge rate at 60 minutes
change in pulse, respiratory rate, and oxygen saturation at 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2005 (estimated)
- Study startSep 2001
- Study completionApr 2004
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 The Hospital for Sick ChildrenThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 129 participants
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Dennis Scolnik, The Hospital for Sick Children
- Investigators
- Dennis Scolnik, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00230841
- Sponsor's protocol ID
- 0020010158
- Status last verified
- Jul 2013
- First submitted
- 29 Sep 2005
- Last updated
- 2 Aug 2013
- Results posted
- No
Publications
Scolnik D, Coates AL, Stephens D, Da Silva Z, Lavine E, Schuh S. Controlled delivery of high vs low humidity vs mist therapy for croup in emergency departments: a randomized controlled trial. JAMA. 2006 Mar 15;295(11):1274-80. doi: 10.1001/jama.295.11.1274.
PubMed 16537737
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Optimal Versus 'Traditional' Delivery of Humidity in Children With Croup
- ClinicalTrials.gov ID
- NCT00230841
- Acronym / sponsor ID
- 0020010158
- Conditions
- Croup
- Keywords
- croup, humidity therapy, pediatrics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Sep 2001
- Study completion
- Apr 2004
- First posted
- 3 Oct 2005 (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 affects 5% of children under 6 years of age, resulting in visits to hospital Emergency Departments, and in 1% of children, hospitalization. Traditionally, the first therapy offered is humidification which can liquify airway secretions and decrease airway swelling. This study will compare the effectivenesss of 40% and 100% humidity through a specially designed machine called a nebulizer, with the usual humidity set-up (blown into the patient's face from a hose).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 3 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children aged 3 months - 10 years
- croup score greater than or equal to 2 after a 30 minute waiting period
Key exclusion criteria (8 listed)
- Symptoms of croup requiring immediate intervention with nebulized epinephrine or intubation
- symptoms or signs of alternative causes of stridor
- inability of caregivers to understand or speak English and/or sign for informed consent
- history of chronic pulmonary disease except for asthma, or co-existent systemic disease
- previous history of intubation
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 |
|---|---|---|
| nebulized humidity | Device | – |
Primary outcome
changes in the croup score from baseline to 30 and 60 minutes
3 secondary outcomes
steroid or epinephrine treatment at 60 minutes
discharge rate at 60 minutes
change in pulse, respiratory rate, and oxygen saturation at 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2013.
- Results publication: PubMed 16537737Scolnik D, Coates AL, Stephens D, Da Silva Z, Lavine E, Schuh S. Controlled delivery of high vs low humidity vs mist therapy for croup in emergency departments: a randomized controlled trial. JAMA. 2006 Mar 15;295(11):1274-80. doi: 10.1001/jama.295.11.1274.
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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.
Dennis Scolnik, MD principal investigator
The Hospital for Sick Children, Toronto Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nebulized humidity in people with Croup, run by The Hospital for Sick Children at 1 site in Canada.
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 8 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: finished, as of the sponsor's last update on 2 Aug 2013. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in the croup score from baseline to 30 and 60 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 NCT00230841, 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 2 Aug 2013.