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| ID | Type | Description | Link |
|---|---|---|---|
| NIH/NCRR UL1RR024992 |
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| Name | Class |
|---|---|
| Washington University Pediatric and Adolescent Ambulatory Research Consortium | NETWORK |
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This randomized clinical trial was to compare the effectiveness of prednisone 2mg/kg/day for 3 days vs. dexamethasone 0.6mg/kg for 1 day for treatment of children with mild or moderate croup. It was conducted in a practice-based research network of community pediatricians in the St. Louis area. Outcomes included additional health care for croup, duration of symptoms, nights of disturbed sleep, parental stress, missed work days, and adverse events. Our hypothesis was that community-based treatment of children with mild or moderate croup with multiple doses of prednisone is superior to a single dose of dexamethasone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisone | Active Comparator | Prednisone, 2mg/kg for 3 days |
|
| Dexamethasone | Active Comparator | Dexamethasone, 0.6mg/kg for one day, then placebo for 2 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug | 2 mgs/kg for 3 days |
| |
| Dexamethasone |
| Measure | Description | Time Frame |
|---|---|---|
| Additional Health Care | The primary outcome was the % of participants who had additional health care for croup within 11 days of randomization assessed by self-report. This dichotomous variable was positive if any of the following occurred: office visit, ED visit or hospitalization for croup care. | 11 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Croup Symptoms | 12 days | |
| Nights With Disturbed Sleep | 12 days | |
| Parental Stress |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane M Garbutt, MB, ChB | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24092872 | Result | Garbutt JM, Conlon B, Sterkel R, Baty J, Schechtman KB, Mandrell K, Leege E, Gentry S, Stunk RC. The comparative effectiveness of prednisolone and dexamethasone for children with croup: a community-based randomized trial. Clin Pediatr (Phila). 2013 Nov;52(11):1014-21. doi: 10.1177/0009922813504823. Epub 2013 Oct 3. |
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103 children were assessed for eligibility. 16 were excluded prior to randomization. reasons were: did not meet inclusion criteria (10), declined to participte (6).
Children were recruited from 10 primary care pediatric practices over two winters: between October 26, 2009 and April 16, 2010; and between September 6, 2010 and April 29, 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Prednisone | |
| FG001 | Dexamethasone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prednisone | |
| BG001 | Dexamethasone | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Additional Health Care | The primary outcome was the % of participants who had additional health care for croup within 11 days of randomization assessed by self-report. This dichotomous variable was positive if any of the following occurred: office visit, ED visit or hospitalization for croup care. | Posted | Number | 95% Confidence Interval | percentage of participants | 11 days |
|
|
28 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 | Prednisone |
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Our failure to demonstrate any difference bewteen the two study groups may be due to the small sample size. We were unable to recruit the targeted sample size of 200.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jane Garbutt | Washington University School of Medicine | 314-454-8613 | jgarbutt@dom.wustl.edu |
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| ID | Term |
|---|---|
| D003440 | Croup |
| ID | Term |
|---|---|
| D007827 | Laryngitis |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
0.6 mgs for one day, then placebo for 2 days |
|
Parental stress due to the child's illness was rated using a 4-point categorical scale (ranging from 3-very stressed to 0-not stressed). We report days until the stress rating was 0.
| 12 days |
| Time Missed From Work | 12 days |
| Number of Participants With Reported Side Effects | 12 days |
Total of all reporting groups
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Duration of Croup Symptoms | Posted | Mean | Standard Deviation | days | 12 days |
|
|
|
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| Secondary | Nights With Disturbed Sleep | Posted | Mean | Standard Deviation | nights | 12 days |
|
|
|
| Secondary | Parental Stress | Parental stress due to the child's illness was rated using a 4-point categorical scale (ranging from 3-very stressed to 0-not stressed). We report days until the stress rating was 0. | Posted | Mean | Standard Deviation | days | 12 days |
|
|
|
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| Secondary | Time Missed From Work | Posted | Mean | Standard Deviation | Hours | 12 days |
|
|
|
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| Secondary | Number of Participants With Reported Side Effects | Posted | Number | percentage of participants | 12 days |
|
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Dexamethasone | 0 | 46 | 0 | 46 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011246 | Pregnadienetriols |
| D013259 | Steroids, Fluorinated |