A Phase 4 interventional study of Prednisone and Dexamethasone in Croup, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 1 Year to 8 Years. Per ClinicalTrials.gov, last updated 2014-09-15.
Sponsored by Washington University School of Medicine · Phase 4, Interventional, and Treatment
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.
18 studies on the registry are indexed under Croup; 2 are open to participants now.
This study's enrollment of 87 is close to the median of 86 across 12 interventional studies indexed under Croup.
Browse Croup studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prednisone, 2mg/kg for 3 days
Drug: Prednisone
Dexamethasone, 0.6mg/kg for one day, then placebo for 2 days
Drug: Dexamethasone
2 mgs/kg for 3 days
0.6 mgs for one day, then placebo for 2 days
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.
Time frame: 11 days
Duration of Croup Symptoms
Time frame: 12 days
Nights With Disturbed Sleep
Time frame: 12 days
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.
Time frame: 12 days
Time Missed From Work
Time frame: 12 days
Number of Participants With Reported Side Effects
Time frame: 12 days
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.
| Milestone | Prednisone | Dexamethasone |
|---|---|---|
| Started | 41 | 46 |
| Completed | 40 | 45 |
| Not completed | 1 | 1 |
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.
| percentage of participants | Prednisone | Dexamethasone |
|---|---|---|
| Additional Health Care | 7 (1.5 to 19.9) | 2 (0 to 11.5) |
| days | Prednisone | Dexamethasone |
|---|---|---|
| Duration of Croup Symptoms | 2.2 ± 1.3 | 2.8 ± 2.7 |
| nights | Prednisone | Dexamethasone |
|---|---|---|
| Nights With Disturbed Sleep | 1.21 ± 2.69 | 0.68 ± 1.55 |
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.
| days | Prednisone | Dexamethasone |
|---|---|---|
| Parental Stress | 1.56 ± 2.69 | 1.39 ± 1.08 |
| Hours | Prednisone | Dexamethasone |
|---|---|---|
| Time Missed From Work | 3.79 ± 7.40 | 4.06 ± 5.54 |
| percentage of participants | Prednisone | Dexamethasone |
|---|---|---|
| Number of Participants With Reported Side Effects | 26 | 24 |
Collected over 28 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prednisone | — | 0/41 (0%) | 0/41 (0%) |
| Dexamethasone | — | 0/46 (0%) | 0/46 (0%) |
| Age, Categorical(Participants) | Prednisone | Dexamethasone | Total |
|---|---|---|---|
| <=18 years | 41 | 46 | 87 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Prednisone | Dexamethasone | Total |
|---|---|---|---|
| Mean | 2.67 ± 1.43 | 3.11 ± 1.58 | 2.9 ± 1.5 |
| Sex: Female, Male(Participants) | Prednisone | Dexamethasone | Total |
|---|---|---|---|
| Female | 13 | 18 | 31 |
| Male | 28 | 28 | 56 |
| Region of Enrollment(participants) | Prednisone | Dexamethasone | Total |
|---|---|---|---|
| United States | 41 | 46 | 87 |
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Prednisone · Dexamethasone
Washington University School of Medicine →