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Australian New Zealand Clinical Trials Registry

Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 083722
ACTR Number: ACTRN12609000290291
Trial Status: Registered
Date Submitted: 16/03/2009
Date Registered: 18/05/2009

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Public title: A comparison of oral prednisolone and oral dexamethasone in children with croup: a prospective, randomised, double blinded multicentre trial
ANZCTR registration title: Oral Prednisolone vs oral Dexamethasone (in two different doses) in children with croup: Randomised Clinical Trial comparing the improvement in Westley Croup Score.
Secondary ID: 
UTN:
Trial acronym: ToPDoG (Trial of Prednisolone / Dexamethasone oral Glucocorticoid)

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Health condition(s) or problem(s) studied:
Croup (laryngotracheitis, laryngotracheobronchitis) 
Condition category: Condition code:
Respiratory Other respiratory disorders / diseases 

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Description of intervention(s) / exposure: Group 1 - oral prednisolone 1 mg/kg oral liquid, single dose;
Group 2 - oral dexamethasone 0.15 mg/kg oral liquid, single dose;
Intervention code:Treatment: drugs 
Comparator / control treatment: Group 3 - oral dexamethasone 0.6 mg/kg oral liquid, single dose
Control group: Active

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Primary outcome 1:Westley Croup Score (a validated measure of croup severity, based on clinical observations of stridor, retractions, air entry, cyanosis, and level of consciousness) 
Timepoint:0, 1, 2, 3, 4, 5, 6, 12 hours after the treatment is administered 
Primary outcome 2:Unscheduled medical re-attendance rate, as assessed by follow-up telephone call 
Timepoint:During the 7 days post-treatment 
Secondary outcome 1:Incidence of Vomiting 
Timepoint:During 30 minute interval following dose 
Secondary outcome 2:Duration of stay in the Emergency Department 
Timepoint:From time of triage to discharge-ready time and actual discharge time 
Secondary outcome 3:Duration of hospital admission or observation 
Timepoint:From time of triage to discharge-ready time and actual discharge time 
Secondary outcome 4:Admission rate to Emergency Department Observation ward 
Timepoint:During initial enrolment visit 
Secondary outcome 5:Admission rate to hospital ward 
Timepoint:During initial enrolment visit 
Secondary outcome 6:Need for nebulised adrenaline (epinephrine), as recorded by treating staff, ie whether or not nebulised adrenaline was administered (decision at the discretion of treating doctor). 
Timepoint:Prior to oral steroid dose, after oral steroid dose (during initial enrolment visit) 
Secondary outcome 7:Admission rate to Intensive Care Unit 
Timepoint:During initial enrolment visit 
Secondary outcome 8:Need for definitive airway (tracheal intubation or surgical airway), as recorded by treating staff, ie whether or not a definitive airway was placed (decision at the discretion of treating doctor). 
Timepoint:During initial enrolment visit 
Secondary outcome 9:Number of additional doses of steroid given after trial drug 
Timepoint:During the 7 days post-treatment (including the period of initial enrolment visit) 
Secondary outcome 10:Unscheduled Hospital re-attendance rate 
Timepoint:During the 7 days post-treatment 
Secondary outcome 11:Hospital re-admission rate for croup symptoms (stridor or breathing difficulty), as assessed by follow-up telephone call 
Timepoint:During the 7 days post-treatment 
Secondary outcome 12:Hospital re-admission rate for non-croup symptoms 
Timepoint:During the 7 days post-treatment 
Secondary outcome 13:Adverse clinical events, other than vomiting (for example skin rash, changes in behaviour or appetite), as reported by treating staff and as reported by caregivers at follow-up telephone call 
Timepoint:During initial enrolment visit, during 7 days post-treatment 

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Key inclusion criteria: Clinical diagnosis of croup
Age 6 months to 10 years
Weight no more than 20 kg
Parents contactable by telephone
Parents speak English
Minimum Age: 6 Months
Maximum Age: 10 Years
Gender: Both males and females
Healthy volunteers? No
Key exclusion criteria: High clinical suspicion of an alternative diagnosis, Known allergy to prednisolone or dexamethasone, Immunosuppressive disease or treatment, Steroid therapy in past 14 days, Enrolment in this study in past 14 days

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Study type: Interventional
Purpose of the study: Treatment
Allocation to intervention: Randomised controlled trial
Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures): Dispensing rack dispenses numbered, otherwise indentical opaque bottles of medication, in set sequence as packaged. Weight-based dosing of medication with different concentrations, ensures same volume of 0.3ml/kg for all subjects. Palatability affects outcome measures (vomiting), therefore smell and taste of the 3 treatments are not controlled for.
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation): Computerised randomisation process administered by clinical trials pharmacist and stratified per centre.
Masking / blinding: Blinded (masking used)
Who is/are masked/blinded: The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Assignment: Parallel
Other design features (specify):
Type of endpoint(s): Efficacy

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Phase Phase 4
Anticipated or actual date of first participant enrolement: 18/03/2009
Target sample size: 1400
Recruitment status: Open to recruitment

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Funding source:Charities/Societies/Foundations 
Name:Princess Margaret Hospital Foundation 
Address:254 Railway Parade, West Leederville, WA 6007 
Country:Australia 
Primary sponsor: Individual
Name: Dr Colin Parker
Address: Emergency Department, Princess Margaret Hospital for Children Roberts Road Subiaco 6008 Western Australia
Country: Australia
Secondary sponsor:Individual 
Name:Dr Gareth Kameron 
Address:Emergency Department, Princess Margaret Hospital for Children Roberts Road Subiaco 6008 Western Australia 
Country:Australia 
Other collaborator: 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name 1:Princess Margaret Hospital Ethics Commitee 
Address:Princess Margaret Hospital for Children, Roberts Road Subiaco 6008 Western Australia 
Country:Australia 
Date of approval: 
HREC Number:1371/EP 
Ethics Committee name 2:Joondalup Health Campus Ethics Committee 
Address:Joondalup Health Campus Shenton Avenue Joondalup 6027 Western Australia 
Country:Australia 
Date of approval: 
HREC Number: 
Countries of recruitment:Australia 
Postcode:6008, 6027 
Brief summary: This clinical trial is designed to test whether the three commonly used oral steroid treatment regimes for croup, are equally effective. Children will receive one of the three treatments, decided by a random process, and their improvement and outcomes monitored by investigators who are blinded to the treatment received.
Trial website:
Presentations / publication list:

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Contact person for public queries
Name: Dr Colin Parker
Address: Princess Margaret Hospital for Children,
Roberts Road
Subiaco 6008
Western Australia
Country: Australia
Tel: +61 8 9340 8380
Fax:
Email: Colin.Parker@health.wa.gov.au

Contact person for scientific queries
Name: Dr Colin Parker
Address: Princess Margaret Hospital for Children,
Roberts Road
Subiaco 6008
Western Asutralia
Country: Australia
Tel: +61 8 9340 8380
Fax:
Email: Colin.Parker@health.wa.gov.au

Contact person responsible for updating information
Name: Dr Colin Parker
Address: Princess Margaret Hospital for Children,
Roberts Road
Subiaco 6008
Western Australia
Country: Australia
Tel:
Fax:
Email: Colin.Parker@health.wa.gov.au
   
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