Trial registered on ANZCTR


Trial ID
ACTRN12609000290291
Ethics application status
Approved
Date submitted
16/03/2009
Date registered
18/05/2009
Date last updated
11/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of oral prednisolone and oral dexamethasone in children with croup: a prospective, randomised, double blinded multicentre trial
Scientific 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 [1] 288279 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ToPDoG
(Trial of Prednisolone / Dexamethasone oral Glucocorticoid)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Croup (laryngotracheitis, laryngotracheobronchitis) 4480 0
Condition category
Condition code
Respiratory 4755 4755 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
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 [1] 4227 0
Treatment: drugs
Comparator / control treatment
Group 3 - oral dexamethasone 0.6 mg/kg oral liquid, single dose
Control group
Active

Outcomes
Primary outcome [1] 5622 0
Westley Croup Score (a validated measure of croup severity, based on clinical observations of stridor, retractions, air entry, cyanosis, and level of consciousness)
Timepoint [1] 5622 0
0, 1, 2, 3, 4, 5, 6, 12 hours after the treatment is administered
Primary outcome [2] 5623 0
Unscheduled medical re-attendance rate, as assessed by follow-up telephone call
Timepoint [2] 5623 0
During the 7 days post-treatment
Secondary outcome [1] 9462 0
Incidence of Vomiting
Timepoint [1] 9462 0
During 30 minute interval following dose
Secondary outcome [2] 9463 0
Duration of stay in the Emergency Department
Timepoint [2] 9463 0
From time of triage to discharge-ready time and actual discharge time
Secondary outcome [3] 9464 0
Duration of hospital admission or observation
Timepoint [3] 9464 0
From time of triage to discharge-ready time and actual discharge time
Secondary outcome [4] 9465 0
Admission rate to Emergency Department Observation ward
Timepoint [4] 9465 0
During initial enrolment visit
Secondary outcome [5] 9466 0
Admission rate to hospital ward
Timepoint [5] 9466 0
During initial enrolment visit
Secondary outcome [6] 9467 0
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 [6] 9467 0
Prior to oral steroid dose, after oral steroid dose (during initial enrolment visit)
Secondary outcome [7] 9468 0
Admission rate to Intensive Care Unit
Timepoint [7] 9468 0
During initial enrolment visit
Secondary outcome [8] 9469 0
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 [8] 9469 0
During initial enrolment visit
Secondary outcome [9] 9470 0
Number of additional doses of steroid given after trial drug
Timepoint [9] 9470 0
During the 7 days post-treatment (including the period of initial enrolment visit)
Secondary outcome [10] 9471 0
Unscheduled Hospital re-attendance rate
Timepoint [10] 9471 0
During the 7 days post-treatment
Secondary outcome [11] 9472 0
Hospital re-admission rate for croup symptoms (stridor or breathing difficulty), as assessed by follow-up telephone call
Timepoint [11] 9472 0
During the 7 days post-treatment
Secondary outcome [12] 9473 0
Hospital re-admission rate for non-croup symptoms
Timepoint [12] 9473 0
During the 7 days post-treatment
Secondary outcome [13] 9474 0
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 [13] 9474 0
During initial enrolment visit, during 7 days post-treatment

Eligibility
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
Can healthy volunteers participate?
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1554 0
6008
Recruitment postcode(s) [2] 1555 0
6027

Funding & Sponsors
Funding source category [1] 4672 0
Charities/Societies/Foundations
Name [1] 4672 0
Princess Margaret Hospital Foundation
Address [1] 4672 0
68 Hay Street, Subiaco, WA 6008
Country [1] 4672 0
Australia
Primary sponsor type
Individual
Name
Dr Colin Parker
Address
Emergency Department,
Princess Margaret Hospital for Children
Roberts Road
Subiaco 6008
Western Australia
Country
Australia
Secondary sponsor category [1] 4218 0
Individual
Name [1] 4218 0
Dr Gareth Kameron
Address [1] 4218 0
Emergency Department,
Princess Margaret Hospital for Children
Roberts Road
Subiaco 6008
Western Australia
Country [1] 4218 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6709 0
Princess Margaret Hospital Ethics Commitee
Ethics committee address [1] 6709 0
Princess Margaret Hospital for Children,
Roberts Road
Subiaco 6008
Western Australia
Ethics committee country [1] 6709 0
Australia
Date submitted for ethics approval [1] 6709 0
Approval date [1] 6709 0
15/02/2009
Ethics approval number [1] 6709 0
1371/EP
Ethics committee name [2] 6711 0
Joondalup Health Campus Ethics Committee
Ethics committee address [2] 6711 0
Joondalup Health Campus
Shenton Avenue
Joondalup 6027
Western Australia
Ethics committee country [2] 6711 0
Australia
Date submitted for ethics approval [2] 6711 0
Approval date [2] 6711 0
Ethics approval number [2] 6711 0

Summary
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
Trial related presentations / publications
Not applicable
Public notes

Contacts
Principal investigator
Name 29401 0
Dr Colin Parker
Address 29401 0
Emergency Department, Princess Margaret Hospital for Children
Roberts Road
Subiaco
6008
Western Australia
Country 29401 0
Australia
Phone 29401 0
+61 8 9340 8222
Fax 29401 0
Email 29401 0
colin.parker@health.wa.gov.au
Contact person for public queries
Name 12648 0
Dr Colin Parker
Address 12648 0
Princess Margaret Hospital for Children,
Roberts Road
Subiaco 6008
Western Australia
Country 12648 0
Australia
Phone 12648 0
+61 8 9340 8380
Fax 12648 0
Email 12648 0
Colin.Parker@health.wa.gov.au
Contact person for scientific queries
Name 3576 0
Dr Colin Parker
Address 3576 0
Princess Margaret Hospital for Children,
Roberts Road
Subiaco 6008
Western Asutralia
Country 3576 0
Australia
Phone 3576 0
+61 8 9340 8380
Fax 3576 0
Email 3576 0
Colin.Parker@health.wa.gov.au