A Phase 3 interventional study of heliox and oxygen in Bronchiolitis, sponsored by University of Louisville. Completed at 1 site in United States. Open to participants aged 2 Months to 12 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-20.
Sponsored by University of Louisville · Phase 3, Interventional, and Treatment
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.
365 studies on the registry are indexed under Bronchiolitis; 45 are open to participants now.
This study's enrollment of 72 is close to the median of 80 across 251 interventional studies indexed under Bronchiolitis.
Browse Bronchiolitis studies →University of Louisville is the lead sponsor of 290 studies on the registry; 53 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 7 (35%) have results posted.
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Exclusion Criteria:
heliox-driven nebulizations for children with moderate to severe bronchiolitis
Drug: heliox
oxygen-driven nebulizations for children with moderate to severe bronchiolitis
Drug: oxygen
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.
Time frame: 240 Minutes
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.
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
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.
Time frame: 0, 60, 120, 180 and 240 mins
This study was conducted from October 1, 2004 through May 31, 2008 in the emergency department of an urban, tertiary care children's hospital.
| Milestone | Heliox | Oxygen |
|---|---|---|
| Started | 36 | 36 |
| Completed | 34 | 35 |
| Not completed | 2 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Protocol violation | 1 | 1 |
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.
| units on a scale | Heliox | Oxygen |
|---|---|---|
| Change in Modified Wood's Clinical Asthma Score (M-WCAS) From Baseline to 240 Minutes | 1.84 (0 to 10) | .031 (0 to 10) |
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.
| units on a scale | Heliox | Oxygen |
|---|---|---|
| Differenceof MWCBS at 0 mins | -0.33 (-0.71 to 0.59) | 0 (0 to 0) |
| Difference of MWCBS at 60 mins | 0.54 (0.18 to 0.91) | 0 (0 to 0) |
| Difference of MWCBS at 120 mins | 0.77 (0.45 to 1.09) | 0 (0 to 0) |
| Difference of MWCBS at 180 mins | 0.94 (0.63 to 1.26) | 0 (0 to 0) |
| Difference of MWCBS at 240 mins | 1.20 (0.87 to 1.54) | 0 (0 to 0) |
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.
| units on a scale | Heliox | Oxygen |
|---|---|---|
| Difference between RDAI at 0 min | -0.48 (-1.55 to 0.59) | 0 (0 to 0) |
| Difference of RDAI at 60 mins | 1.80 (0.55 to 3.07) | 0 (0 to 0) |
| Difference of RDAI at 120 mins | 2.92 (1.77 to 4.07) | 0 (0 to 0) |
| Difference of RDAI at 180 mins | 3.00 (1.99 to 4.01) | 0 (0 to 0) |
| Difference of RDAI at 240 mins | 3.29 (2.35 to 4.23) | 0 (0 to 0) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Heliox | 0/34 (0%) | 0/34 (0%) | 0/34 (0%) |
| Oxygen | 0/35 (0%) | 0/35 (0%) | 0/35 (0%) |
Seventy-two subjects initially met inclusion criteria; but only 69 were in final analysis.
| Age, Continuous(Months) | Heliox | Oxygen | Total |
|---|---|---|---|
| Mean | 5.09 (2 to 12) | 6.11 (2 to 12) | 5.6 (2 to 12) |
| Sex: Female, Male(Participants) | Heliox | Oxygen | Total |
|---|---|---|---|
| Female | 11 | 11 | 22 |
| Male | 23 | 24 | 47 |
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Heliox · Oxygen