BronchiolitisPhase 3NCT00116584
Heliox-Driven Racemic Epinephrine in Treatment of Bronchiolitis in Pediatric ED Patients
A Phase 3 study testing heliox and oxygen in people with Bronchiolitis, run by University of Louisville at 1 site in United States.
Trial summary
The purpose of this study is to assess whether children with moderate to severe bronchiolitis treated with standard racemic epinephrine therapy via 70:30 helium-oxygen (heliox) driven nebulization will have improvements in measurements of airway more rapidly than those treated with conventional air-oxygen driven… Read more about this study
- Who is it for?
- Ages 2 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- heliox and oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Oct 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Any child 2-12 months old seen in the emergency department.
- A clinical bronchiolitis score > 3 by modified Wood's Clinical Bronchiolitis Score (M-WCBS).
- Diagnostic criteria of bronchiolitis includes tachypnea, cough, prolonged expiratory phase, wheezing, rales, chest retractions, and hyperinflation of lungs on chest radiograph. After consenting a patient to the study, respiratory syncytial virus (RSV) infection will be tested by rapid enzyme-linked immunoabsorbent assay of nasal secretions.
Who cannot join
- No child will be excluded based on race or gender
- Patients under the age of 2 months or greater than 12 months
- Patients with cyanotic heart disease
- Patients with lobar pneumonia, defined by results of chest radiographs.
- The presence of interstitial disease or diffuse patchy marking consistent with atelectasis on chest radiographs will not exclude patients.
- Patients with croup.
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- Patients with foreign body aspiration.
- Patients with history of cystic fibrosis, bronchopulmonary dysplasia or other chronic lung disease.
- Patients with liver or renal disease.
- Patients with sickle cell anemia.
- Patients requiring mechanical ventilation.
- Patients who develop supraventricular tachycardia secondary to racemic epinephrine administration.
- Patients with tracheomalacia or bronchomalacia.
- Patients who had received bronchodilators within 2 hours of initiation of the study.
- Patients who had received systemic corticosteroids within 72 hours of enrollment
- Patients who suffered from persistent airway hyperreactivity in the 3 months before the study.
- Patients who do not tolerate the nasal cannulae for 45 out of 60 minutes.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kosair Children's Hospital
Louisville, Kentucky, 40202
About this study
Official title: The Use of Heliox Driven Racemic Epinephrine Nebulization in the Treatment of Moderate to Severe Bronchiolitis in Pediatric Emergency Department Patients
The purpose of this study is to assess whether children with moderate to severe bronchiolitis treated with standard racemic epinephrine therapy via 70:30 helium-oxygen (heliox) driven nebulization will have improvements in measurements of airway more rapidly than those treated with conventional air-oxygen driven nebulization.
- Conditions
- Bronchiolitis
- Being tested
- heliox, oxygen
- Keywords
- heliox, bronchiolitis, racemic epinephrine
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
helioxDrug
continuous heliox therapy
oxygenDrug
continuous oxygen therapy
| Study group | Role | What they receive |
|---|---|---|
| heliox | Other | heliox-driven nebulizations for children with moderate to severe bronchiolitis Receives: Drug: heliox |
| oxygen | Other | oxygen-driven nebulizations for children with moderate to severe bronchiolitis Receives: Drug: oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 240 Minutes
The Modified Wood's clinical Asthma Score is a score to measure severity of Asthma in children. There are 5 variables measured: oxygen saturation, inspiratory breath sounds, expiratory wheezing, accessory muscle involvement and cerebral function. Each variable is given a score of 0, 0.5, 1 or 2 with 2 being the most severe. The scores are combined from each variable to give a total. Total score ranges from 0 to 10, with a score of 10 (higher the score) indicating a worse outcome. We are reporting the degree of improvement in M-WCAS after assigned treatment.
Measured: 240 Minutes
Secondary outcomes (2)
Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times
The Modified Wood's Clinical Bronchiolitis Score is based on a rating of saturated oxygen, inspiratory breath sounds, expiratory wheezing, accessory muscle use, cerebral function and wheezing. Each variable is rated 0, 0.5, 1, or 2. The total range of score is 0 to 2, with 2 (higher the score) indicating a worse outcome. For this outcome, a negative difference between groups represents an improvement.
Measured: 0, 60, 120, 180 and 240 min
Change in Respiratory Distress Assessment Instrument (RDAI) Scores in Oxygen and Heliox Groups at Different Times
The RDAI is an assessment instrument for respiratory distress. Patients are assigned a point value based on Wheezing (on expiration, inspiration and location) and Retractions (local of supraclavicular, intercostal and subcostal). Each subcategory is assigned a value of 0-4. The subscores are summed to give a total score for each variable (wheezing and retractions). The total score range for wheezing is 0 to 8, with 8 (higher the score) indicating a worse outcome. The total score range for retractions is 0 to 9, with 9 (higher the score) indicating a worse outcome. We are reporting the difference in score between the groups at various times, not a change from an earlier time. A positive value represents an improvement in the Heliox vs the Oxygen groups.
Measured: 0, 60, 120, 180 and 240 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2005 (estimated)
- Study startDec 2004
- Primary completionMar 2008
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In K. Kim, University of Louisville
- Investigators
- In K Kim, MD, Principal investigator, University of Louisville, Dept. of Pediatrics, Div. of Pediatric Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116584
- Sponsor's protocol ID
- GRNT040954
- Other IDs
- GRNT040954, G040954
- Status last verified
- May 2020
- First submitted
- 29 Jun 2005
- Last updated
- 20 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kim IK, Phrampus E, Sikes K, Pendleton J, Saville A, Corcoran T, Gracely E, Venkataraman S. Helium-oxygen therapy for infants with bronchiolitis: a randomized controlled trial. Arch Pediatr Adolesc Med. 2011 Dec;165(12):1115-22. doi: 10.1001/archpediatrics.2011.605.
PubMed 22147778
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Heliox Driven Racemic Epinephrine Nebulization in the Treatment of Moderate to Severe Bronchiolitis in Pediatric Emergency Department Patients
- ClinicalTrials.gov ID
- NCT00116584
- Acronym / sponsor ID
- GRNT040954
- Conditions
- Bronchiolitis
- Keywords
- heliox, bronchiolitis, racemic epinephrine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Mar 2008 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 30 Jun 2005 (estimated)
- Results
- Posted 20 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess whether children with moderate to severe bronchiolitis treated with standard racemic epinephrine therapy via 70:30 helium-oxygen (heliox) driven nebulization will have improvements in measurements of airway more rapidly than those treated with conventional air-oxygen driven nebulization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| heliox | Other | Drug: helioxheliox-driven nebulizations for children with moderate to severe bronchiolitis |
| oxygen | Other | Drug: oxygenoxygen-driven nebulizations for children with moderate to severe bronchiolitis |
Who may qualify
- Ages
- 2 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Any child 2-12 months old seen in the emergency department.
- A clinical bronchiolitis score > 3 by modified Wood's Clinical Bronchiolitis Score (M-WCBS).
- Diagnostic criteria of bronchiolitis includes tachypnea, cough, prolonged expiratory phase, wheezing, rales, chest retractions, and hyperinflation of lungs on chest radiograph. After consenting a patient to the study, respiratory syncytial virus (RSV) infection will be tested by rapid enzyme-linked immunoabsorbent assay of nasal secretions.
Key exclusion criteria (17 listed)
- No child will be excluded based on race or gender
- Patients under the age of 2 months or greater than 12 months
- Patients with cyanotic heart disease
- Patients with lobar pneumonia, defined by results of chest radiographs.
- The presence of interstitial disease or diffuse patchy marking consistent with atelectasis on chest radiographs will not exclude patients.
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 |
|---|---|---|
| helioxcontinuous heliox therapy | Drug | heliox |
| oxygencontinuous oxygen therapy | Drug | oxygen |
Primary outcome
Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 240 Minutes
Time frame: 240 Minutes
The Modified Wood's clinical Asthma Score is a score to measure severity of Asthma in children. There are 5 variables measured: oxygen saturation, inspiratory breath sounds, expiratory wheezing, accessory muscle involvement and cerebral function. Each variable is given a score of 0, 0.5, 1 or 2 with 2 being the most severe. The scores are combined from each variable to give a total. Total score ranges from 0 to 10, with a score of 10 (higher the score) indicating a worse outcome. We are reporting the degree of improvement in M-WCAS after assigned treatment.
2 secondary outcomes
Change in Modified Wood's Clinical Bronchiolitis Score (MWCBS) Between Oxygen and Heliox Groups at Various Times
Time frame: 0, 60, 120, 180 and 240 min
Change in Respiratory Distress Assessment Instrument (RDAI) Scores in Oxygen and Heliox Groups at Different Times
Time frame: 0, 60, 120, 180 and 240 mins
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22147778Kim IK, Phrampus E, Sikes K, Pendleton J, Saville A, Corcoran T, Gracely E, Venkataraman S. Helium-oxygen therapy for infants with bronchiolitis: a randomized controlled trial. Arch Pediatr Adolesc Med. 2011 Dec;165(12):1115-22. doi: 10.1001/archpediatrics.2011.605.
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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.
In K Kim, MD principal investigator
University of Louisville, Dept. of Pediatrics, Div. of Pediatric Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing heliox and oxygen in people with Bronchiolitis, run by University of Louisville at 1 site in United States.
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 3 inclusion and 17 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 20 May 2020. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 240 Minutes (time frame: 240 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 NCT00116584, 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 20 May 2020.