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Prednisolone in Preschool wheeze

In children between age 1 and 5 years with salbutamol responsive wheeze does treatment with prednisolone compared with placebo result in lower PRAM at 24 hours?

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000590864
Acronym
WASP (Wheeze And Steroids in Pre-schooler's)
Enrollment
200
Registered
2012-06-01
Start date
2012-06-05
Completion date
2013-01-20
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

Wheeze in preschool children is the most common cause of admission to hospital in the age group. In older children and adults, oral corticosteroids are proven to be an effective treatment for wheeze (asthma). However a similar treatment effect has not been demonstrated in the preschool population and effective treatment for preschool wheeze has proved to be difficult to find. There have only been a handful of studies on the clinical effects of corticosteroids (usually prednisolone) in preschool children with wheeze. These have typically been small studies, had some study design problems and have produced conflicting results – some suggesting they work, some suggesting they don’t. So currently no-one knows whether to continue to give preschool children with wheeze steroids. Administrationof steroids preschool wheeze use is included in clinical guidelines in New Zealand and internationally. However current practice varies greatly and often depends on personal presence. None of the previous trials have measured salbutamol response or used this to guide treatment, although this is currently used by clinicians to help guide treatment. Salbutamol response is an indicator of airway responsiveness and we hypothesise that a positive response is likely to increase the chance of steroids being effective. We aim to determine the clinical effect of oral corticosteroids in salbutamol responsive preschool wheeze

Interventions

2mg/kg of prednisolone. Orally, Once Daily for 3 days.

Sponsors

Dr Richard Aickin,
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
12 Months to 59 Months
Healthy volunteers
No

Inclusion criteria

Preschool age. Presenting with an acute respiratory illness to the Emergency Department of Starship Childrens Hospital. Wheeze. A significant clinical response to Salbutamol. This will be asses using a standard scoring measure, The PRAM score.

Exclusion criteria

Unable to be followed up in 20-36 hours. Corticosteriods in last 7 days. Chronic respiratory, neurological or cardiac disease. Contraindication to corticosteriods or allergy to prednisolone. History consistent with foreign body inhalation. Current severe disease (i.e. life threatening asthma). History of life threatening asthma. Previously randomised to the WASP study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026