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A comparison of oral prednisolone and oral dexamethasone in children with croup: a prospective, randomised, double blinded multicentre trial

Oral Prednisolone vs oral Dexamethasone (in two different doses) in children with croup: Randomised Clinical Trial comparing the improvement in Westley Croup Score.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000290291
Acronym
ToPDoG (Trial of Prednisolone / Dexamethasone oral Glucocorticoid)
Enrollment
1252
Registered
2009-05-18
Start date
2009-03-27
Completion date
2012-07-19
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

Group 1 - oral prednisolone 1 mg/kg oral liquid, single dose; Group 2 - oral dexamethasone 0.15 mg/kg oral liquid, single dose;

Sponsors

Dr Colin Parker
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
6 Months to 10 Years
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026