Objective To determine if administration of oral prednisolone to preschool children with acute wheeze alters respiratory outcomes.
Design Double-blind, randomised, placebo-controlled equivalence trial.
Setting Three hospitals in New Zealand.
Patients 477 children aged 24–59 months with acute wheeze associated with respiratory illness.
Interventions 2 mg/kg (maximum 40 mg) oral prednisolone or similar placebo, once daily for 3 days.
Main outcome measures Primary outcome was change in Preschool Respiratory Assessment Measure (PRAM) score 24 hours after intervention. Secondary outcomes included PRAM score at 4 hours, length of emergency department and inpatient stays, admission and representation rates, time to return to normal activities and use of additional oral prednisolone or intravenous medications. Analysis was by intention-to-treat.
Results There was no difference between groups for change in PRAM score at 24 hours (difference between means −0.39, 95% CI −0.84 to 0.06, p=0.09). Absolute PRAM score was lower in the prednisolone group at 4 hours (median (IQR) 1 (0–2) vs 2 (0–3), p=0.01) and 24 hours (0 (0–1) vs 0 (0–1), p=0.01), when symptoms had resolved for most children regardless of initial treatment. Admission rate, requirement for additional oral prednisolone and use of intravenous medication were lower in the prednisolone group, although there were no differences between groups for time taken to return to normal activities or rates of representation within 7 days.
Conclusion Oral prednisolone does not alter respiratory outcomes at 24 hours or beyond in preschool children presenting with acute wheeze.
- general paediatrics
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Contributors SRD, DWJ, IA, OS, MS, DM, JMDT, AT and MB contributed to the study design. OS, MS, SRD and MB undertook the pilot study, and AW, MS, JN, AT, ET, CB, SRD and MB undertook the main study. SRD obtained funding. NG developed the study database. SRD and JMDT had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. AW prepared the draft manuscript, and all authors contributed to and reviewed the manuscript. SRD approved the final manuscript and is responsible for the overall content as guarantor. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.
Funding This study was funded by the Health Research Council of New Zealand (13/556). The researchers in the WASP study were independent of the funders. All authors had full access to all of the data (including statistical reports and tables) in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis. SRD’s time is partly funded by Cure Kids New Zealand.
Disclaimer The funders had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript and decision to submit the manuscript for publication.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval Approved by the Northern-A Health and Disability Ethics Committee (New Zealand) (HDEC14/NTA/83) and participating hospitals.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request. The authors support data sharing. The WASP trial used identifiable individual patient data that are subject to restriction, including ethics, consent and privacy issues. Anonymised (deidentified) data will be available on request from the corresponding author (Professor Stuart R Dalziel email@example.com), where possible within these constraints for use, following review by the trial steering committee of the protocol and statistical analysis plan.
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