Effectiveness of a cough management algorithm at the transitional phase from acute to chronic cough in Australian children aged <15 years: Protocol for a randomised controlled trial

Kerry Ann F O'Grady, Keith Grimwood, Maree Toombs, Theo P Sloots, Michael Otim, David M Whiley, Jennie Anderson, Sheree Rablin, Paul J. Torzillo, Helen Buntain, Anne Connor, Don Adsett, Oon Meng kar, Anne B. Chang

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    Abstract

    Introduction: Acute respiratory infections (ARIs) are leading causes of hospitalisation in Australian children and, if recurrent, are associated with increased risk of chronic pulmonary disorders later in life. Chronic (>4â €..weeks) cough in children following ARI is associated with decreased quality-of-life scores and increased health and societal economic costs. We will determine whether a validated evidence-based cough algorithm, initiated when chronic cough is first diagnosed after presentation with ARI, improves clinical outcomes in children compared with usual care.

    Methods and analysis: A multicentre, parallel group, open-label, randomised controlled trial, nested within a prospective cohort study in Southeast Queensland, Australia, is underway. 750 children aged <15â €..years will be enrolled and followed weekly for 8â €..weeks after presenting with an ARI with cough. 214 children from this cohort with persistent cough at day 28 will be randomised to either early initiation of a cough management algorithm or usual care (107 per group). Randomisation is stratified by reason for presentation, site and total cough duration at day 28 (<6 and ≥6â €..weeks). Demographic details, risk factors, clinical histories, examination findings, cost-of-illness data, an anterior nasal swab and parent and child exhaled carbon monoxide levels (when age appropriate) are collected at enrolment. Weekly contacts will collect cough status and cost-of-illness data. Additional nasal swabs are collected at days 28 and 56. The primary outcome is time-To-cough resolution. Secondary outcomes include direct and indirect costs of illness and the predictors of chronic cough postpresentation.

    Ethics and dissemination: The Children's Health Queensland (HREC/15/QRCH/15) and the Queensland University of Technology University (1500000132) Research Ethics Committees have approved the study. The study will inform best-practice management of cough in children.

    Trial registration number: ACTRN12615000132549.

    Original languageEnglish
    Article numbere013796
    Pages (from-to)1-12
    Number of pages12
    JournalBMJ Open
    Volume7
    Issue number3
    DOIs
    Publication statusPublished - 1 Mar 2017

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    O'Grady, K. A. F., Grimwood, K., Toombs, M., Sloots, T. P., Otim, M., Whiley, D. M., Anderson, J., Rablin, S., Torzillo, P. J., Buntain, H., Connor, A., Adsett, D., Meng kar, O., & Chang, A. B. (2017). Effectiveness of a cough management algorithm at the transitional phase from acute to chronic cough in Australian children aged <15 years: Protocol for a randomised controlled trial. BMJ Open, 7(3), 1-12. [e013796]. https://doi.org/10.1136/bmjopen-2016-013796