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).

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000847617

Acronym

WASP: Main study

Enrollment

400

Registered

2014-08-07

Start date

2014-08-18

Completion date

2016-12-31

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

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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

24 Months to 59 Months

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Outcome results