Dexamethasone Versus Prednisone for Asthma Treatment in the Pediatric Inpatient Population; a Feasibility Study
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|ClinicalTrials.gov Identifier: NCT03133897|
Recruitment Status : Terminated (it was felt by the sponsoring institution that the current standard of oversight expected by the Health Canada regulations, would not be possible to achieve)
First Posted : April 28, 2017
Last Update Posted : September 7, 2020
Current corticosteroid regimens for children hospitalized with asthma typically include a 5-day course of prednisone or prednisolone. However, these medications taste poorly and are associated with vomiting and poor compliance. Outpatient evidence suggests that a 2-day course of dexamethasone is as effective as a longer course of prednisone and prednisolone, and better tolerated. Studies in hospitalized patients are lacking.
The investigators' primary objective is to determine the feasibility of a non-inferiority trial, comparing 2 days of dexamethasone to 4 days of inpatient prednisone/prednisolone for inpatient asthma treatment. The investigators also wish to determine the feasibility of 1) enrolling patients upon admission to hospital, 2) asking patients and/or caregivers to complete a symptom weekly for 4 weeks, 3) reassessing patients post hospital discharge, 4) successfully completing phone follow up 4 weeks post hospital discharge, and 5) collecting health utilization data post hospital discharge.
This study will inform a future multi-site trial comparing prednisone/prednisolone to dexamethasone in inpatient asthma treatment. It has the potential of improving the delivery of care in asthma, by improving compliance with a mainstay of treatment. It will also enhance collaboration within Ontario pediatric hospitals, facilitating knowledge translation and standardization of care across institutions.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Dexamethasone Drug: Prednisone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Dexamethasone Versus Prednisone for Asthma Treatment in the Pediatric Inpatient Population; a Feasibility Study|
|Actual Study Start Date :||March 5, 2018|
|Actual Primary Completion Date :||August 2, 2019|
|Actual Study Completion Date :||March 11, 2020|
Active Comparator: Prednisone
Prednisone group: Children will receive four doses (days) of prednisone 1 mg/kg/dose once daily (maximum dose 50 mg) following the initial dose of corticosteroid received in the ED under the Nursing Medical Directive or Pre-Printed Order form.
control group will receive 4 day treatment
Dexamethasone group: Children will receive the approximate pharmacologic equivalent of two doses (days) of dexamethasone 0.6 mg/kg/dose (maximum dose 16 mg per dose) once daily as follows. The standard dose of prednisone/prednisolone provided in the emergency department is 2 mg/kg/dose (maximum dose 50 mg), which is approximately equivalent to 0.3 mg/kg/dose of dexamethasone. Therefore, patients who received prednisone/prednisolone in emergency department as per the current Nursing Medical Directive and Pre-Printed Order form will receive a "top-up" These patients will then receive a dose of dexamethasone 0.6 mg/kg (maximum dose 16 mg) 24 hours after the initial corticosteroid dose received in the Emergency Department of dexamethasone 0.3 mg/kg (maximum dose 8 mg) upon enrollment.
experimental group will receive 2 day treatment
- Health Utilization [ Time Frame: 4 weeks ]Readmission to hospital, repeat ED visit within 4 weeks for asthma, or unplanned visits to primary health care providers for asthma symptoms.
- Allocation success [ Time Frame: 4 weeks ]
proportion receiving assigned CS as per randomization group
(1) proportion receiving assigned CS as per randomization group proportion receiving assigned corticosteroid as per randomization group
- recruitment success [ Time Frame: 1 year ]number screened, number eligible, number enrolled
- compliance with symptom reporting [ Time Frame: 4 weeks after discharge ]Compliance with reporting symptoms in diary
- Retention rate [ Time Frame: 4 weeks ]Proportion of patients coming back for follow-up visits and Proportion of patients reached at 4-week follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133897
|Children's Hospital of Eastern Ontario|
|Ottawa, Ontario, Canada, K1H 8L1|