CompletedPhase 4ACTRN12609000290291

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.


Sponsor

Dr Colin Parker

Enrollment

1,400 participants

Start Date

Mar 27, 2009

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 6 MonthssMax Age: 10 Yearss

Inclusion Criteria5

  • Clinical diagnosis of croup
  • Age 6 months to 10 years
  • Weight no more than 20 kg
  • Parents contactable by telephone
  • Parents speak English

Exclusion Criteria5

  • 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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Interventions

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

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


Locations(1)

Australia

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ACTRN12609000290291