An evaluation of prednisolone to treat viral associated wheeze in pre-school aged children.

A prospective, randomised, double blinded, non-inferiority trial assessing the impact of oral prednisolone on hospital length of stay in pre-school aged children presenting with viral associated wheeze.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000394842

Acronym

PREVIEW

Enrollment

608

Registered

2012-04-05

Start date

2012-06-11

Completion date

2015-06-11

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 oral corticosteroids are effective in treating children of pre-schol age presenting with wheeze associated with viral upper respiratory tract illness.

Interventions

Oral prednisolone 1mg/kg once daily for 3 days.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

24 Months to 72 Months

Healthy volunteers

Inclusion criteria

1. Clinical diagnosis of wheeze. 2. Presence of symptoms or signs of an intercurrent or recent (within 72hrs) viral upper respiratory tract infection.

Exclusion criteria

1. Presenting oxygen saturation (SpO2) less than 92% in room air. 2. Features of "critical wheeze" - (silent chest on auscultation and/or exhaustion with or without cyanosis) 3. Clinical evidence of shock or bacterial sepsis. 4. Active varicella infection. 5. High clinical suspicion of alternative diagnosis for wheeze (for example - inhaled foreign body). 6. Previous PICU admission with wheeze / asthma. 7. Premature birth - defined as <34 weeks gestation. 8. Known cardiac / other respiratory disease. 9. Recieving immunosuppresant therapy or known to have immunodeficiency. 10. Upper respiratory tract structural abnormality. 11. Oral corticosteroid therapy within the last 14 days. 12. Previously recruited to this study. 13. Known allergy to Prednisolone.

Outcome results