Dexamethasone versus prednisone for children receiving asthma treatment in the paediatric inpatient population: protocol for a feasibility randomised controlled trial
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Catherine M Pound1, Jaime McDonald2, Ken Tang3
1Department of Pediatrics, University of Ottawa, Children's Hospital of Eastern Ontario, Ottawa, Ontario, Canada.
Insights
This study assesses a short dexamethasone course versus prednisone for pediatric asthma hospitalizations. It aims to improve treatment compliance and inform future large-scale trials on pediatric asthma management.
Area of Science:
- Pediatric Pulmonology
- Clinical Pharmacology
- Health Services Research
Background:
- Asthma exacerbations are a primary cause of pediatric hospitalizations.
- Current standard treatment involves a 5-day course of prednisone or prednisolone, often leading to poor compliance due to taste and vomiting.
- Limited evidence exists for using dexamethasone in inpatient pediatric asthma treatment.
Purpose of the Study:
- To determine the feasibility of a non-inferiority trial comparing dexamethasone and prednisone/prednisolone for hospitalized children with asthma.
- To evaluate the safety and tolerability of both treatment regimens.
- To gather preliminary data on clinical outcomes, including hospital readmissions and healthcare utilization, to inform future trials.
Main Methods:
- A single-site, pragmatic, feasibility randomized controlled trial involving 51 children aged 18 months to 17 years.
- Participants were randomized to receive either a short course of dexamethasone or a longer course of prednisone/prednisolone.
- Primary feasibility outcomes included recruitment success, compliance, retention, and safety; the primary clinical outcome was readmission or repeat ED visits within 4 weeks of discharge.
Main Results:
- This section is marked as 'Pre-results' and no specific findings are available.
- Feasibility outcomes such as recruitment, compliance, retention, and safety will be analyzed.
- Preliminary comparisons of clinical outcomes between the two groups will provide insights into probable effect sizes for a future trial.
Conclusions:
- The study's findings will guide a larger multi-site trial comparing dexamethasone and prednisone/prednisolone for inpatient pediatric asthma treatment.
- Successful implementation of this trial could lead to improved compliance and better asthma care delivery for hospitalized children.
- Results will be disseminated through publications and presentations to inform clinical practice and research.
Introduction:
Asthma exacerbations are a leading cause of paediatric hospitalisations. Corticosteroids are key in the treatment of asthma exacerbations. Most current corticosteroids treatment regimens for children admitted with asthma exacerbation consist of a 5-day course of prednisone or prednisolone. However, these medications are associated with poor taste and significant vomiting, resulting in poor compliance with the treatment course. While some centres already use a short course of dexamethasone for treating children hospitalised with asthma, there is no evidence to support this practice in the inpatient population.
Methods And Analysis:
This single-site, pragmatic, feasibility randomised controlled trial will determine the feasibility of a non-inferiority trial, comparing two treatment regimens for children admitted to the hospital and receiving asthma treatment. Children 18 months to 17 years presenting to a Canadian tertiary care centre will be randomised to receive either a short course of dexamethasone or a longer course of prednisone/prednisolone once admitted to the inpatient units. The primary clinical outcome for this feasibility study will be readmission to hospital or repeat emergency department visits, or unplanned visits to primary healthcare providers for asthma symptoms within 4 weeks of hospital discharge. Feasibility outcomes will include recruitment and allocation success, compliance with study procedures, retention rate, and safety and tolerability of study medications. We plan on recruiting 51 children, and between-group comparisons of the clinical outcome will be conducted to gain insights on probable effect sizes.
Ethics And Dissemination:
Research Ethics Board approval has been obtained for this study. The results of this study will inform a multisite trial comparing prednisone/prednisolone to dexamethasone in inpatient asthma treatment, which will have the potential to improve the delivery of asthma care, by improving compliance with a mainstay of treatment. Results will be disseminated through peer-reviewed publications, organisations and meetings.
Trial Registration Number:
NCT03133897; Pre-results.
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