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Comparing one versus two doses of oral dexamethasone for the treatment of asthma in the pediatric emergency department.
A randomized double blinded placebo controlled trial comparing one dose of dexamethasone administered in the Emergency Department with two doses, the first given in the emergency department and the second 24 hours after the index ED visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and a second dose of 0.6 milligrams per kilogram up to 16 milligrams to take 24 hours after ED visit |
|
| Investigational | Experimental | Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and placebo to be taken 24 hours after ED visit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug |
|
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Failure | number of patients who experience any of the following outcomes - unplanned hospital admission for asthma symptoms, unplanned ED visit for asthma symptoms, unplanned urgent care visit for asthma symptoms, unplanned primary care physician visit for asthma symptoms, or prescription of a course of steroids | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Symptom Severity From Day 1 to Day 5 | Severity of asthma symptoms as reported by the Patient Self Assessment Score. Patients assessed severity of asthma symptoms in 4 categories (wheezing, coughing, activity and sleep) once per day during the 5 days between study enrollment and follow-up. Score range is 0 - 12 with 0 being mildest symptoms and 12 being most severe symptoms. Reported as change in score between enrollment (day 1) and follow-up (day 5). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Kelly, MD | New York Presbyterian Brooklyn Methodist Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Methodist Hospital | Brooklyn | New York | 11215 | United States |
99 participants were enrolled, 2 participants underwent initial enrollment but were not randomized to a group, leaving 97 participants who were assigned to a study group.
Pediatric Emergency Department
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and a second dose of 0.6 milligrams per kilogram up to 16 milligrams to take 24 hours after ED visit Dexamethasone |
| FG001 | Investigational | Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and placebo to be taken 24 hours after ED visit Dexamethasone placebo: to be given to the experimental group on the day after discharge from the ED in lieu of the second dose of dexamethasone |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and a second dose of 0.6 milligrams per kilogram up to 16 milligrams to take 24 hours after ED visit Dexamethasone |
| BG001 | Investigational |
| 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 | Treatment Failure | number of patients who experience any of the following outcomes - unplanned hospital admission for asthma symptoms, unplanned ED visit for asthma symptoms, unplanned urgent care visit for asthma symptoms, unplanned primary care physician visit for asthma symptoms, or prescription of a course of steroids | Posted | Count of Participants | Participants | 5 days |
|
Duration of study participation - 5 days
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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 | Control | Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and a second dose of 0.6 milligrams per kilogram up to 16 milligrams to take 24 hours after ED visit Dexamethasone |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
Target enrollment was not reached.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher P Kelly | New York Presbyterian - Brooklyn Methodist Hospital | 718.780.5040 | chk9064@nyp.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 13, 2015 | Nov 30, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Drug |
to be given to the experimental group on the day after discharge from the ED in lieu of the second dose of dexamethasone |
|
| 5 days |
| Admitted to hospital |
|
Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and placebo to be taken 24 hours after ED visit Dexamethasone placebo: to be given to the experimental group on the day after discharge from the ED in lieu of the second dose of dexamethasone |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| PIS Score | Pulmonary Index Score - a clinical tool to assess severity of asthma exacerbation in children. Includes respiratory rate, amount of wheezing, I:E ratio, degree of accessory muscle use and oxygen saturation. Each subsection may be scored 0-3. Total score is arrived bu summation of sub-scores. Score range 0-15. Lower score corresponds to milder disease. <7 is considered mild, 7-12 moderate. Responsiveness to ED therapy (assessed by PIS Score at End of ED Stay) is expected to be an independent risk factor for the primary outcome, therefore it is considered a Baseline Measure. | Median | Standard Deviation | units on a scale |
|
|
|
|
| Secondary | Change in Symptom Severity From Day 1 to Day 5 | Severity of asthma symptoms as reported by the Patient Self Assessment Score. Patients assessed severity of asthma symptoms in 4 categories (wheezing, coughing, activity and sleep) once per day during the 5 days between study enrollment and follow-up. Score range is 0 - 12 with 0 being mildest symptoms and 12 being most severe symptoms. Reported as change in score between enrollment (day 1) and follow-up (day 5). | Participants who had complete data available for analysis | Posted | Median | Standard Deviation | score on a scale | 5 days |
|
|
|
|
| 0 |
| 46 |
| 1 |
| 46 |
| 1 |
| 46 |
| EG001 | Investigational | Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and placebo to be taken 24 hours after ED visit Dexamethasone placebo: to be given to the experimental group on the day after discharge from the ED in lieu of the second dose of dexamethasone | 1 | 51 | 1 | 51 | 1 | 51 |
| Hospitalization | General disorders | Systematic Assessment |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |