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| ID | Type | Description | Link |
|---|---|---|---|
| GRNT040954 | |||
| G040954 | Other Grant/Funding Number | Praxair Healthcare |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| heliox | Other | heliox-driven nebulizations for children with moderate to severe bronchiolitis |
|
| oxygen | Other | oxygen-driven nebulizations for children with moderate to severe bronchiolitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| heliox | Drug | continuous heliox therapy |
| |
| oxygen |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 240 Minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| In K Kim, MD | University of Louisville, Dept. of Pediatrics, Div. of Pediatric Emergency Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kosair Children's Hospital | Louisville | Kentucky | 40202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22147778 | Result | 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. |
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This study was conducted from October 1, 2004 through May 31, 2008 in the emergency department of an urban, tertiary care children's hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Heliox | Patients were randomized to the helium-oxygen received nebulized racemic epinephrine via a face mask. |
| FG001 | Oxygen | Patients were randomized to 100% oxygen group and received nebulized racemic epinephrine via a face mask. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Seventy-two subjects initially met inclusion criteria; but only 69 were in final analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Heliox | heliox-driven nebulizations for children with moderate to severe bronchiolitis |
| BG001 | Oxygen | Oxygen nebulizations for children with moderate to severe bronchiolitis |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Full Range | units on a scale | 240 Minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Heliox | heliox-driven nebulizations for children with moderate to severe bronchiolitis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. In Kim | ULouisville | 502-629-7212 | in.kim@louisville.edu |
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| ID | Term |
|---|---|
| D001988 | Bronchiolitis |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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| ID | Term |
|---|---|
| C038949 | heliox |
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| Drug |
continuous oxygen therapy |
|
| 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. | 0, 60, 120, 180 and 240 mins |
| BG002 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Oxygen |
Oxygen nebulizations for children with moderate to severe bronchiolitis |
|
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 0, 60, 120, 180 and 240 min |
|
|
|
|
| Secondary | 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. | The Respiratory Distress Assessment Instrument (RDAI) has been used extensively. It is one of the most commonly used clinical scores for bronchiolitis,. | Posted | Mean | 95% Confidence Interval | units on a scale | 0, 60, 120, 180 and 240 mins |
|
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Oxygen | Oxygen nebulizations for children with moderate to severe bronchiolitis | 0 | 35 | 0 | 35 | 0 | 35 |
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| D012140 |
| Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| Difference of MWCBS at 120 mins |
|
| Difference of MWCBS at 180 mins |
|
| Difference of MWCBS at 240 mins |
|
| Difference of RDAI at 120 mins |
|
| Difference of RDAI at 180 mins |
|
| Difference of RDAI at 240 mins |
|