title: 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.
abstract: 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 (>4 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.
  
  
  
  A multicentre, parallel group, open-label, randomised controlled trial, nested within a prospective cohort study in Southeast Queensland, Australia, is underway. 750 children aged <15 years will be enrolled and followed weekly for 8 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 ≥6 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.
  
  
  
  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.
  
  
  
  ACTRN12615000132549.
authors.affiliation: Centre for Children's Health Research, Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Queensland, Australia.
authors.forename: Kerry-Ann F
authors.identifier: 0000-0002-8159-2620
authors.initials: KF
authors.lastname: O'Grady
authors.affiliation: Menzies Health Institute Queensland, Griffith University and Gold Coast Health, Southport, Queensland, Australia.
authors.forename: Keith
authors.initials: K
authors.lastname: Grimwood
authors.affiliation: The University of Queensland Rural Clinical School, The University of Queensland, Toowoomba, Queensland, Australia.|Carbal Health Services, Toowoomba, Queensland, Australia.|Menzies School of Health Research, Charles Darwin University, Casuarina, Northern Territory, Australia.
authors.forename: Maree
authors.initials: M
authors.lastname: Toombs
authors.affiliation: Queensland Paediatric Infectious Diseases Laboratory, Children's Health Queensland, Brisbane, Queensland, Australia.|Faculty of Medicine and Biomedical Sciences, The University of Queensland, Herston, Queensland, Australia.
authors.forename: Theo P
authors.initials: TP
authors.lastname: Sloots
authors.affiliation: School of Public Health, Australian Catholic University, Sydney, New South Wales, Australia.
authors.forename: Michael
authors.initials: M
authors.lastname: Otim
authors.affiliation: Faculty of Medicine and Biomedical Sciences, The University of Queensland, Herston, Queensland, Australia.
authors.forename: David
authors.initials: D
authors.lastname: Whiley
authors.affiliation: Caboolture Community Medical, Caboolture, Queensland, Australia.
authors.forename: Jennie
authors.initials: J
authors.lastname: Anderson
authors.affiliation: Centre for Children's Health Research, Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Queensland, Australia.
authors.forename: Sheree
authors.initials: S
authors.lastname: Rablin
authors.affiliation: School of Medicine, The University of Sydney, Newtown, New South Wales, Australia.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Torzillo
authors.affiliation: Wesley Medical Centre, Brisbane, Queensland, Australia.
authors.forename: Helen
authors.initials: H
authors.lastname: Buntain
authors.affiliation: Ferny Grove Chambers Medical Practice, Brisbane, Queensland, Australia.
authors.forename: Anne
authors.initials: A
authors.lastname: Connor
authors.affiliation: Department of Paediatrics, Toowoomba Hospital, Toowoomba, Queensland, Australia.
authors.forename: Don
authors.initials: D
authors.lastname: Adsett
authors.affiliation: Department of Paediatrics, Toowoomba Hospital, Toowoomba, Queensland, Australia.
authors.forename: Oon
authors.initials: O
authors.lastname: Meng Kar
authors.affiliation: Centre for Children's Health Research, Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Queensland, Australia.|Menzies School of Health Research, Charles Darwin University, Casuarina, Northern Territory, Australia.|Queensland Children's Respiratory Centre, Lady Cilento Children's Hospital, Brisbane, Queensland, Australia.
authors.forename: Anne B
authors.initials: AB
authors.lastname: Chang
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000465:Algorithms; D002648:Child; D002908:Chronic Disease; D015331:Cohort Studies; D003371:Cough / Q000503:physiopathology* / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011793:Queensland; D012107:Research Design
keywords: children; chronic cough; cost effectiveness; intervention; randomised controlled trial