OBJECTIVES: The use of either prednisolone or low-dose dexamethasone in the treatment of childhood croup lacks a rigorous evidence base despite widespread use. In this study, we compare dexamethasone at 0.6 mg/kg with both low-dose dexamethasone at 0.15 mg/kg and prednisolone at 1 mg/kg. METHODS: Prospective, double-blind, noninferiority randomized controlled trial based in 1 tertiary pediatric emergency department and 1 urban district emergency department in Perth, Western Australia. Inclusions were age .6 months, maximum weight 20 kg, contactable by telephone, and English-speaking caregivers. Exclusion criteria were known prednisolone or dexamethasone allergy, immunosuppressive disease or treatment, steroid therapy or enrollment in the study within the previous 14 days, and a high clinical suspicion of an alternative diagnosis. A total of 1252 participants were enrolled and randomly assigned to receive dexamethasone (0.6 mg/kg; n = 410), low-dose dexamethasone (0.15 mg/kg; n = 410), or prednisolone (1 mg/kg; n = 411). Primary outcome measures included Westley Croup Score 1-hour after treatment and unscheduled medical re-attendance during the 7 days after treatment. RESULTS: Mean Westley Croup Score at baseline was 1.4 for dexamethasone, 1.5 for low-dose dexamethasone, and 1.5 for prednisolone. Adjusted difference in scores at 1 hour, compared with dexamethasone, was 0.03 (95% confidence interval 20.09 to 0.15) for low-dose dexamethasone and 0.05 (95% confidence interval 20.07 to 0.17) for prednisolone. Reattendance rates were 17.8% for dexamethasone, 19.5% for low-dose dexamethasone, and 21.7% for prednisolone (not significant [P = .59 and .19]). CONCLUSIONS: Noninferiority was demonstrated for both low-dose dexamethasone and prednisolone. The type of oral steroid seems to have no clinically significant impact on efficacy, both acutely and during the week after treatment. WHAT'S KNOWN ON THIS SUBJECT: Although dexamethasone at 0.6 mg/kg is an established evidence-based treatment of childhood croup (reducing hospital admissions, length of stay, and need for endotracheal intubation), alternative corticosteroid regimes are in widespread use based on evidence from small studies and observational data. WHAT THIS STUDY ADDS: With our study, we confirm that prednisolone at 1 mg/kg and dexamethasone at 0.15 mg/kg are both noninferior to dexamethasone at 0.6 mg/kg for the treatment of croup in children. We found no difference between groups for both acute croup severity and unscheduled medical re-attendance after treatment.
I thank Nathan Emmerich for his response and think it would be helpful if I replied to his consideration of my first part of the 'debate' in the recent issue of Research Ethics Review [1]. Generally, it seems to me
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