RecruitingPhase 3ACTRN12614000847617

Wheeze and Steroids in Preschoolers: Main study

In children aged between 24 and 59 months, presenting to emergency departments with acute preschool wheeze associated with a respiratory tract infection, is oral prednisolone 2mg/kg for 3 days equivalent to placebo in terms of respiratory distress measured at 24 hours by the Preschool Respiratory Assessment Measure (PRAM score).


Sponsor

Auckland District Health Board

Enrollment

400 participants

Start Date

Aug 18, 2014

Study Type

Interventional

Conditions

Summary

In school age children and adults we know prednisolone helps to reduce the length of wheezing. In children less than two years of age we know that prednisolone does not help children who wheeze. The few scientific studies that have been carried out in preschool children to assess the effect of prednisolone have had conflicting results. No one knows for sure if prednisolone helps preschool children with wheeze or not. Currently preschool children with wheeze are sometimes given prednisolone and sometimes they are not. We don’t know if giving prednisolone or not is the best treatment. The aim of this study is to determine if prednisolone helps to reduce the symptoms in preschool children with wheeze.


Eligibility

Sex: Both males and femalesMin Age: 24 MonthssMax Age: 59 Monthss

Inclusion Criteria3

  • Age 24 to 59 months
  • Wheeze heard with or without a stethoscope
  • Presenting with an acute respiratory illness

Exclusion Criteria9

  • PRAM score < 3
  • Unable to be followed up in 18-38 hours
  • Corticosteroid in last 7 days
  • Chronic respiratory, neurological or cardiac disease
  • Contraindication to corticosteroid or allergy to prednisilone
  • History consistent with foreign body inhalation
  • Currently severe disease (i.e using life threatening asthma protocol or in resuscitation room)
  • History of life threatening asthma
  • Previously randomised in WASP study

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Interventions

2mg/kg oral prednisilone, once daily for 3 days. First dose will be directly observed, adherence to doses 2 and 3 will be via parental report without additional monitoring.

2mg/kg oral prednisilone, once daily for 3 days. First dose will be directly observed, adherence to doses 2 and 3 will be via parental report without additional monitoring.


Locations(1)

New Zealand

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ACTRN12614000847617