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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
87
2 mgs/kg for 3 days
0.6 mgs for one day, then placebo for 2 days
Washington University School of Medicine
St Louis, Missouri, United States
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
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