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Trial registered on ANZCTR


Registration number
ACTRN12605000447651
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
21/09/2005
Date last updated
13/11/2019
Date data sharing statement initially provided
13/11/2019
Date results information initially provided
13/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison between single dose oral prednisolone and oral dexamethasone in the treatment of croup: a randomised, double-blind clinical trial.
Scientific title
A randomised, double-blind clinical trial comparing the
effectiveness of single dose oral prednisolone versus single dose oral
dexamethasone in reducing the severity of croup in children presenting to
the Emergency Department, as measured by changes in the Westley croup
score.
Secondary ID [1] 299815 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Croup (laryngotracheobronchitis) 562 0
Condition category
Condition code
Respiratory 637 637 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three steroid preparations are being compared in a
double-blinded, randomised trial. Children aged 6 months
to 6 years presenting to Brisbane's Mater Childrens' Hospital Emergency
Department (MCH ED) with moderate severity croup (defined in the study as
Westley croup score 2-7) are randomised to one of three treatment groups:
oral dexamethasone 0.6mg/kg, oral dexamethasone 0.15mg/kg, or prednisolone
1mg/kg. After administration of their oral dose of steroid treatment, the
children are observed in the ED for up to 4 hours, with hourly measurement
of their Westley croup score. Subjects are able to be discharged from ED
earlier than 4 hours if much improved; if they are still significantly
symptomatic at 4hrs they may be admitted to the ward for observation.
Salvage therapy such as nebulised adrenaline can be provided at the
discretion of the treating doctor. The subject's discharge or admission is
at the discretion of the ED clinician looking after the patient. If the
child re-presented to a health care facility following the index
presentation, additional treatment was at the discretion of the treating
doctor. A phone call was made to the parents of enrolled children 1-2weeks
after their index presentation to discuss the duration of the child's croup
symptoms, need for medical review with or without further steroids, and to
discuss any noted side effects from the steroid preparation.
Intervention code [1] 433 0
None
Comparator / control treatment
Dexamethasone 0.6mg/kg was assigned as
the standard to compare other treatment assignments.
Control group
Active

Outcomes
Primary outcome [1] 747 0
Magnitude of reduction in Westley croup score, a derived cumulative severity-duration index using area under curve. Enrolled children are randomly provided with one of three oral steroid preparations. The Westley croup score is a validated observational score which scores for level of consciousness, cyanosis, stridor, air entry and retractions.
Timepoint [1] 747 0
The Westley croup scores are then recorded hourly for up to 4 hours on a standardised pro forma data collection sheet. Scoring
continues until the child is discharged from the ED due to clinical improvement or 4hours has elapsed.
Primary outcome [2] 748 0
Rate of reduction in Westley croup score, a derived cumulative severity-duration index using area under curve. Enrolled children are randomly provided with one of three oral steroid
preparations. The Westley croup score is a validated observational score which scores for level of consciousness, cyanosis, stridor, air entry and retractions.
Timepoint [2] 748 0
The Westley croup scores are then recorded hourly for up to 4 hours on a standardised pro forma data collection sheet. Scoring
continues until the child is discharged from the ED due to clinical improvement or 4hours has elapsed.
Secondary outcome [1] 1531 0
(1) Rate of return to medical care with ongoing croup and further treatment with steroids.
Timepoint [1] 1531 0
In the week following initial presentation.
Secondary outcome [2] 1532 0
(2) Rate of hospitalisation and number of co-interventions (including salvage therapy with nebulised adrenaline)
Timepoint [2] 1532 0
Incurred during index presentation.

Eligibility
Key inclusion criteria
(1) Children aged 6 months to 6 years presenting to the ED with a croup syndrome, clinically defined by hoarseness, barking cough and stridor.(2) Westley croup score of 2 or greater(3) Parents available for phone follow-up 1 week after study enrolment.
Minimum age
6 Months
Maximum age
6 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) Chronic respiratory disease (excluding asthma)(2) Severe croup (defined as Westley croup score of >/= 8)(3) Nebulised adrenaline prior to or on arrival to the ED(4) Steroids within the preceding week(5) Known allergy to steroids(6) Varicella or exposure to varicella within the previous 3 weeks(7) Known immunodeficiency.

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)
The 3 steroid preparations were prepared by MCH research pharmacists who were not involved in the design, conduct, analysis and write-up of the study. All study preparations were prepared as clear solutions in equivalent therapeutic concentrations per millilitre, such that each child would receive an identical volume of preparation regardless of treatment assignment allocated to the child. Each treatment (designated A, B, and C) were placed in identical dispensing containers in the study centre. All recruiting and study staff were blinded to the treatment assignments. Codes were kept securely in Pharmacy and could only be revealed to manage adverse sequelae such as anaphylaxis resulting from study participation. Codes will only be revealed to the study investigators after data has been completely analysed to reduce interpretation bias. Children are randomised to receive one of the 3 study preparations in a dose of 0.2ml/kg with 0.2ml containing either 1mg prednisolone, 0.15mg of dexamethasone or 0.6mg of dexamethasone. The study agents were flavoured to standardise taste and palatability.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A pre-specified sample size of 33 patients per treatment group was calculated prior to study commencement. Based on previous similar comparative studies, this sample size would power the study to detect the presence of a true difference (defined as 20% or greater) between treatment assignments, if it existed, to a probability of 80%. A randomised computer generated list of the numbers 1, 2 and 3 (representing treatment A, treatment B and treatment C respectively) provided treatment allocations to an equal proportion of subjects in each group. Every
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / 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)
QLD

Funding & Sponsors
Funding source category [1] 698 0
Hospital
Name [1] 698 0
Mater Childrens' Hospital Department of Paediatric Emergency Medicine
Address [1] 698 0
Emergency Department
Mater Children's Hospital
South Brisbane
Queensland 4101
Country [1] 698 0
Australia
Primary sponsor type
Hospital
Name
Mater Childrens' Hospital Department of Paediatric Emergency Medicine
Address
Emergency Department
Mater Children's Hospital
South Brisbane
QLD 4101
Country
Australia
Secondary sponsor category [1] 583 0
None
Name [1] 583 0
Nil
Address [1] 583 0
Country [1] 583 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1902 0
Mater Childrens' Hospital ED
Ethics committee address [1] 1902 0
Emergency Department
Queensland Children's Hospital
South Brisbane
Queensland
Ethics committee country [1] 1902 0
Australia
Date submitted for ethics approval [1] 1902 0
Approval date [1] 1902 0
07/06/2004
Ethics approval number [1] 1902 0

Summary
Brief summary
Published: Emergency Medicine Australasia (2007) 19, 51–58

ABSTRACT

Objective: To compare the effectiveness of three corticosteroid regimens in children with mild to moderate croup.

Methods: Double-blinded, randomized comparative trial with parallel design, conducted in the ED of a paediatric tertiary care hospital. Children aged 6 months to 6 years presenting to the ED with croup were eligible for inclusion if their Westley croup score was 2 or more. They were randomized to receive a single oral dose of either prednisolone 1 mg/kg, dexamethasone 0.15 mg/kg or dexamethasone 0.6 mg/kg. Primary outcome measures were the magnitude and rate of reduction in Westley croup score, rate of return for medical care with ongoing croup, and further treatment with steroids in the week following index presentation. Secondary outcome measures were the proportion of subjects requiring admission or salvage therapy, such as nebulized adrenaline, during index presentation.

Results: A total of 99 children, aged 6–79 months, were enrolled (mean age: 1.7 years). Thirty-four patients were randomized to receive prednisolone 1 mg/kg, 34 to receive dexamethasone 0.15 mg/kg, and 31 to receive dexamethasone 0.6 mg/kg. Baseline characteristics of the three groups were similar. The parents of 86 patients (87%) were available for follow-up telephone interview at 1 week. There were no significant differences in primary or secondary outcome measures between the three treatment groups.

Conclusions: Both prednisolone 1 mg/kg and low-dose dexamethasone (0.15 mg/kg) were found not to differ in efficacy from the currently recommended 0.6 mg/kg dexamethasone. The use of these corticosteroid regimens in treating patients with mild to moderate croup is thus supported.
Trial website
Trial related presentations / publications
AA Fifoot, JY Ting. Comparison between single-dose oral prednisolone and oral dexamethasone in the treatment of croup: a randomized, double-blinded clinical trial. Emergency Medicine Australasia, 19 (2007), pp. 51–58
Public notes

Contacts
Principal investigator
Name 35601 0
Dr Allison Fifoot
Address 35601 0
Department of Emergency Medicine
The Prince Charles Hospital
Rode Rd, Chermside, QLD 4032
Country 35601 0
Australia
Phone 35601 0
+61 7 31394000
Fax 35601 0
Email 35601 0
fifoota@hotmail.com
Contact person for public queries
Name 9622 0
Dr Dr A Fifoot
Address 9622 0
Department of Emergency Medicine
The Prince Charles Hospital
Rode Rd, Chermside, QLD 4032
Country 9622 0
Australia
Phone 9622 0
+61 7 31394000
Fax 9622 0
+61 7 36368732
Email 9622 0
fifoota@hotmail.com
Contact person for scientific queries
Name 550 0
Dr Dr A Fifoot
Address 550 0
Department of Emergency Medicine
The Prince Charles Hospital
Rode Rd, Chermside, QLD 4032
Country 550 0
Australia
Phone 550 0
+61 7 31394000
Fax 550 0
+61 7 36368732
Email 550 0
fifoota@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The trial was completed over a decade ago so I will not be uploading information for this new requirement. If anyone would like to know more, I am happy to be contacted by email.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 5666 0
Emergency Medicine Australasia (2007) 19, 51–58
Attachments [1] 5666 0
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
Both prednisolone 1mg/kg and low-dose dexamethasone (0.15mg/kg) were found not to differ in efficacy from the currently recommended 0.6mg/kg dexamethasone. The use of these corticosteroid regimens in treating patients with mild to moderate croup is thus supported.