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Readmission rates are high, and novel preventive strategies are required. OM\u201085 is an orally administered bacterial lysate that stimulates anti\u2010viral immune responses and reduces excessive airway inflammation associated with wheezing episodes. The aim of the Assessing the Reduction of Recurrent admissions using OM\u201085 for the treatment of preschool Wheeze (ARROW) trial is to determine the efficacy of OM\u201085 in preventing hospital readmissions in children admitted to hospital with preschool wheeze. The primary outcome is hospital admission due to an acute wheezing illness during the 12\u2010month treatment period. Secondary outcomes include the frequency and duration of wheeze episodes and the cost\u2010effectiveness of the intervention.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>ARROW is a decentralised, Phase 3 randomised, double\u2010blind, placebo\u2010controlled trial. We aim to recruit and follow\u2010up 870 children aged 1 to &lt;\u20096\u2009years. Participants are randomised to 3.5\u2009mg of OM\u201085 or placebo daily for the first 10\u2009days of every month, for 12\u2009months. Health professionals from over 40 hospitals participating in the Children's Inpatient Research Collaboration of Australia and New Zealand (CIRCAN) invite families to the ARROW trial. The ARROW central team organises enrolment, randomisation, medication distribution, and follow\u2010up, conducting these activities entirely remotely in Australia and both remotely and in\u2010person in New Zealand.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and Dissemination<\/jats:title>\n                    <jats:p>ARROW received ethics approval from The Royal Children's Hospital Human Research Ethics Committee in Australia and the Health and Disability Ethics Committee in New Zealand. Findings will be published in peer\u2010reviewed international journals.<\/jats:p>\n                    <jats:p>\n                      <jats:bold>Trial registration:<\/jats:bold>\n                      ANZCTR: ACTRN12620001370998 (Registered on 21 December 2020).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/jpc.70434","type":"journal-article","created":{"date-parts":[[2026,6,15]],"date-time":"2026-06-15T12:17:38Z","timestamp":1781525858000},"page":"1244-1254","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Assessing the Reduction of Recurrent Admissions Using\n                    <scp>OM<\/scp>\n                    \u201085 for the Treatment of Preschool Wheeze (\n                    <scp>ARROW<\/scp>\n                    ): Protocol for a Multi\u2010Centre, Randomised, Double\u2010Blind, Placebo\u2010Controlled Trial"],"prefix":"10.1111","volume":"62","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-4180-1123","authenticated-orcid":false,"given":"Jessica C.","family":"Costa\u2010Pinto","sequence":"first","affiliation":[{"name":"Deakin University  Geelong Victoria Australia"},{"name":"Barwon Health  Geelong Victoria Australia"},{"name":"Box Hill Hospital, Eastern Health  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marisa","family":"van Arragon","sequence":"additional","affiliation":[{"name":"The University of Auckland  Auckland New Zealand"},{"name":"Starship Children's Hospital, Te Whatu Ora\u2014Health New Zealand Te Toka Tumai  Auckland New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8334-0291","authenticated-orcid":false,"given":"Katherine J.","family":"Lee","sequence":"additional","affiliation":[{"name":"Murdoch Children's Research Institute  Parkville Victoria 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