Xylitol for the prevention of acute otitis media episodes in children aged 2–4 years: protocol for a pragmatic randomised controlled trial
IntroductionXylitol (or ‘birch sugar’) is a naturally occurring sugar with antibacterial properties that has been used as a natural non-sugar sweetener in chewing gums, confectionery, toothpaste and medicines. In this preventative randomised trial, xylitol will be tested for the prevention of acute...
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| Veröffentlicht in: | BMJ open 2018-08, Vol.8 (8), p.e020941-e020941 |
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| creator | Persaud, Nav Laupacis, Andreas Azarpazhooh, Amir Birken, Catherine Hoch, Jeffrey S Isaranuwatchai, Wanrudee Maguire, Jonathan L Mamdani, Muhammad M Thorpe, Kevin Allen, Christopher Mason, Dalah Kowal, Christine Bazeghi, Farnaz Parkin, Patricia |
| description | IntroductionXylitol (or ‘birch sugar’) is a naturally occurring sugar with antibacterial properties that has been used as a natural non-sugar sweetener in chewing gums, confectionery, toothpaste and medicines. In this preventative randomised trial, xylitol will be tested for the prevention of acute otitis media (AOM), a common and costly condition in young children. The primary outcome will be the incidence of AOM. Secondary outcomes will include upper respiratory tract infections (URTIs) and dental caries.Methods and analysisThis study will be a pragmatic, blinded (participant and parents, practitioners and analyst), two-armed superiority, placebo-controlled randomised trial with 1:1 allocation, stratified by clinical site. The trial will be conducted in the 11 primary care group practices participating in the TARGet Kids! research network in Canada. Eligible participants between the ages of 2–4 years will be randomly assigned to the intervention arm of regular xylitol syrup use or the control arm of regular sorbitol use for 6 months. We expect to recruit 236 participants, per treatment arm, to detect a 20% relative risk reduction in AOM episodes. AOM will be identified through chart review. The secondary outcomes of URTIs and dental caries will be identified through monthly phone calls with specified questions.Ethics and disseminationEthics approval from the Research Ethics Boards at the Hospital for Sick Children and St. Michael’s Hospital has been obtained for this study and also for the TARGet Kids! research network. Results will be submitted for publication to a peer-reviewed journal and will be discussed with decision makers.Trial registration number NCT03055091; Pre-results. |
| doi_str_mv | 10.1136/bmjopen-2017-020941 |
| format | Article |
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Collaboration</creatorcontrib><description>IntroductionXylitol (or ‘birch sugar’) is a naturally occurring sugar with antibacterial properties that has been used as a natural non-sugar sweetener in chewing gums, confectionery, toothpaste and medicines. In this preventative randomised trial, xylitol will be tested for the prevention of acute otitis media (AOM), a common and costly condition in young children. The primary outcome will be the incidence of AOM. Secondary outcomes will include upper respiratory tract infections (URTIs) and dental caries.Methods and analysisThis study will be a pragmatic, blinded (participant and parents, practitioners and analyst), two-armed superiority, placebo-controlled randomised trial with 1:1 allocation, stratified by clinical site. The trial will be conducted in the 11 primary care group practices participating in the TARGet Kids! research network in Canada. Eligible participants between the ages of 2–4 years will be randomly assigned to the intervention arm of regular xylitol syrup use or the control arm of regular sorbitol use for 6 months. We expect to recruit 236 participants, per treatment arm, to detect a 20% relative risk reduction in AOM episodes. AOM will be identified through chart review. The secondary outcomes of URTIs and dental caries will be identified through monthly phone calls with specified questions.Ethics and disseminationEthics approval from the Research Ethics Boards at the Hospital for Sick Children and St. Michael’s Hospital has been obtained for this study and also for the TARGet Kids! research network. Results will be submitted for publication to a peer-reviewed journal and will be discussed with decision makers.Trial registration number NCT03055091; Pre-results.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2017-020941</identifier><identifier>PMID: 30082349</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Age ; Antibiotics ; Canada ; Caregivers ; Child, Preschool ; Cost analysis ; Dental caries ; Ear diseases ; Evidence-based medicine ; General practice / Family practice ; Humans ; Illnesses ; Medical screening ; Multicenter Studies as Topic ; Otitis Media - prevention & control ; Parents & parenting ; Pediatrics ; Pragmatic Clinical Trials as Topic ; Prevention ; Primary care ; Public health ; Respiratory diseases ; Streptococcus infections ; Sweetening Agents - therapeutic use ; Xylitol - therapeutic use</subject><ispartof>BMJ open, 2018-08, Vol.8 (8), p.e020941-e020941</ispartof><rights>Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.</rights><rights>2018 Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2018</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b472t-bf50cce2e8706ca728f7d21d529dcc7da6515b029044200c11cb46e082f774523</citedby><cites>FETCH-LOGICAL-b472t-bf50cce2e8706ca728f7d21d529dcc7da6515b029044200c11cb46e082f774523</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://bmjopen.bmj.com/content/8/8/e020941.full.pdf$$EPDF$$P50$$Gbmj$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://bmjopen.bmj.com/content/8/8/e020941.full$$EHTML$$P50$$Gbmj$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27526,27527,27901,27902,53766,53768,77343,77374</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30082349$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Persaud, Nav</creatorcontrib><creatorcontrib>Laupacis, Andreas</creatorcontrib><creatorcontrib>Azarpazhooh, Amir</creatorcontrib><creatorcontrib>Birken, Catherine</creatorcontrib><creatorcontrib>Hoch, Jeffrey S</creatorcontrib><creatorcontrib>Isaranuwatchai, Wanrudee</creatorcontrib><creatorcontrib>Maguire, Jonathan L</creatorcontrib><creatorcontrib>Mamdani, Muhammad M</creatorcontrib><creatorcontrib>Thorpe, Kevin</creatorcontrib><creatorcontrib>Allen, Christopher</creatorcontrib><creatorcontrib>Mason, Dalah</creatorcontrib><creatorcontrib>Kowal, Christine</creatorcontrib><creatorcontrib>Bazeghi, Farnaz</creatorcontrib><creatorcontrib>Parkin, Patricia</creatorcontrib><creatorcontrib>TARGet Kids! Collaboration</creatorcontrib><title>Xylitol for the prevention of acute otitis media episodes in children aged 2–4 years: protocol for a pragmatic randomised controlled trial</title><title>BMJ open</title><addtitle>BMJ Open</addtitle><description>IntroductionXylitol (or ‘birch sugar’) is a naturally occurring sugar with antibacterial properties that has been used as a natural non-sugar sweetener in chewing gums, confectionery, toothpaste and medicines. In this preventative randomised trial, xylitol will be tested for the prevention of acute otitis media (AOM), a common and costly condition in young children. The primary outcome will be the incidence of AOM. Secondary outcomes will include upper respiratory tract infections (URTIs) and dental caries.Methods and analysisThis study will be a pragmatic, blinded (participant and parents, practitioners and analyst), two-armed superiority, placebo-controlled randomised trial with 1:1 allocation, stratified by clinical site. The trial will be conducted in the 11 primary care group practices participating in the TARGet Kids! research network in Canada. Eligible participants between the ages of 2–4 years will be randomly assigned to the intervention arm of regular xylitol syrup use or the control arm of regular sorbitol use for 6 months. We expect to recruit 236 participants, per treatment arm, to detect a 20% relative risk reduction in AOM episodes. AOM will be identified through chart review. The secondary outcomes of URTIs and dental caries will be identified through monthly phone calls with specified questions.Ethics and disseminationEthics approval from the Research Ethics Boards at the Hospital for Sick Children and St. Michael’s Hospital has been obtained for this study and also for the TARGet Kids! research network. Results will be submitted for publication to a peer-reviewed journal and will be discussed with decision makers.Trial registration number NCT03055091; Pre-results.</description><subject>Age</subject><subject>Antibiotics</subject><subject>Canada</subject><subject>Caregivers</subject><subject>Child, Preschool</subject><subject>Cost analysis</subject><subject>Dental caries</subject><subject>Ear diseases</subject><subject>Evidence-based medicine</subject><subject>General practice / Family practice</subject><subject>Humans</subject><subject>Illnesses</subject><subject>Medical screening</subject><subject>Multicenter Studies as Topic</subject><subject>Otitis Media - prevention & control</subject><subject>Parents & parenting</subject><subject>Pediatrics</subject><subject>Pragmatic Clinical Trials as Topic</subject><subject>Prevention</subject><subject>Primary care</subject><subject>Public health</subject><subject>Respiratory diseases</subject><subject>Streptococcus infections</subject><subject>Sweetening Agents - therapeutic use</subject><subject>Xylitol - therapeutic use</subject><issn>2044-6055</issn><issn>2044-6055</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>9YT</sourceid><sourceid>ACMMV</sourceid><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqNkc2KFDEUhYMozjDOEwgScOOmxiSVVKpcCDL4BwNuFNyFVHKrO00qKZPUQO98AHe-oU9imm6H0ZXZ5IZ855CTg9BTSq4obbuX47yLC4SGESobwsjA6QN0zgjnTUeEeHhvPkOXOe9IXVwMQrDH6KwlpGctH87Rj69770r0eIoJly3gJcEthOJiwHHC2qwFcCyuuIxnsE5jWFyOFjJ2AZut8zZBwHoDFrNf339yvAed8qvqE0s0J2Ndj3oz6-IMTjrYOLtcBSaGkqL3dSzJaf8EPZq0z3B52i_Ql3dvP19_aG4-vf94_eamGblkpRknQYwBBr0kndGS9ZO0jFrBBmuMtLoTVIyEDfUHGCGGUjPyDmrkSUouWHuBXh99l3WsoUzNm7RXS3KzTnsVtVN_3wS3VZt4qzoie8ZpNXhxMkjx2wq5qBrIgPc6QFyzYqTnA2WS9BV9_g-6i2sKNV6lhoH3raAHqj1SJsWcE0x3j6FEHQpXp8LVoXB1LLyqnt3Pcaf5U28Fro5AVf-X429wgboc</recordid><startdate>20180801</startdate><enddate>20180801</enddate><creator>Persaud, Nav</creator><creator>Laupacis, Andreas</creator><creator>Azarpazhooh, Amir</creator><creator>Birken, Catherine</creator><creator>Hoch, Jeffrey S</creator><creator>Isaranuwatchai, Wanrudee</creator><creator>Maguire, Jonathan L</creator><creator>Mamdani, Muhammad M</creator><creator>Thorpe, Kevin</creator><creator>Allen, Christopher</creator><creator>Mason, Dalah</creator><creator>Kowal, Christine</creator><creator>Bazeghi, Farnaz</creator><creator>Parkin, Patricia</creator><general>BMJ Publishing Group LTD</general><general>BMJ Publishing Group</general><scope>9YT</scope><scope>ACMMV</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>COVID</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20180801</creationdate><title>Xylitol for the prevention of acute otitis media episodes in children aged 2–4 years: protocol for a pragmatic randomised controlled trial</title><author>Persaud, Nav ; Laupacis, Andreas ; Azarpazhooh, Amir ; Birken, Catherine ; Hoch, Jeffrey S ; Isaranuwatchai, Wanrudee ; Maguire, Jonathan L ; Mamdani, Muhammad M ; Thorpe, Kevin ; Allen, Christopher ; Mason, Dalah ; Kowal, Christine ; Bazeghi, Farnaz ; Parkin, Patricia</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b472t-bf50cce2e8706ca728f7d21d529dcc7da6515b029044200c11cb46e082f774523</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Age</topic><topic>Antibiotics</topic><topic>Canada</topic><topic>Caregivers</topic><topic>Child, Preschool</topic><topic>Cost analysis</topic><topic>Dental caries</topic><topic>Ear diseases</topic><topic>Evidence-based medicine</topic><topic>General practice / Family practice</topic><topic>Humans</topic><topic>Illnesses</topic><topic>Medical screening</topic><topic>Multicenter Studies as Topic</topic><topic>Otitis Media - prevention & control</topic><topic>Parents & parenting</topic><topic>Pediatrics</topic><topic>Pragmatic Clinical Trials as Topic</topic><topic>Prevention</topic><topic>Primary care</topic><topic>Public health</topic><topic>Respiratory diseases</topic><topic>Streptococcus infections</topic><topic>Sweetening Agents - therapeutic use</topic><topic>Xylitol - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Persaud, Nav</creatorcontrib><creatorcontrib>Laupacis, Andreas</creatorcontrib><creatorcontrib>Azarpazhooh, Amir</creatorcontrib><creatorcontrib>Birken, Catherine</creatorcontrib><creatorcontrib>Hoch, Jeffrey S</creatorcontrib><creatorcontrib>Isaranuwatchai, Wanrudee</creatorcontrib><creatorcontrib>Maguire, Jonathan L</creatorcontrib><creatorcontrib>Mamdani, Muhammad M</creatorcontrib><creatorcontrib>Thorpe, Kevin</creatorcontrib><creatorcontrib>Allen, Christopher</creatorcontrib><creatorcontrib>Mason, Dalah</creatorcontrib><creatorcontrib>Kowal, Christine</creatorcontrib><creatorcontrib>Bazeghi, Farnaz</creatorcontrib><creatorcontrib>Parkin, Patricia</creatorcontrib><creatorcontrib>TARGet Kids! 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Collaboration</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Xylitol for the prevention of acute otitis media episodes in children aged 2–4 years: protocol for a pragmatic randomised controlled trial</atitle><jtitle>BMJ open</jtitle><addtitle>BMJ Open</addtitle><date>2018-08-01</date><risdate>2018</risdate><volume>8</volume><issue>8</issue><spage>e020941</spage><epage>e020941</epage><pages>e020941-e020941</pages><issn>2044-6055</issn><eissn>2044-6055</eissn><abstract>IntroductionXylitol (or ‘birch sugar’) is a naturally occurring sugar with antibacterial properties that has been used as a natural non-sugar sweetener in chewing gums, confectionery, toothpaste and medicines. In this preventative randomised trial, xylitol will be tested for the prevention of acute otitis media (AOM), a common and costly condition in young children. The primary outcome will be the incidence of AOM. Secondary outcomes will include upper respiratory tract infections (URTIs) and dental caries.Methods and analysisThis study will be a pragmatic, blinded (participant and parents, practitioners and analyst), two-armed superiority, placebo-controlled randomised trial with 1:1 allocation, stratified by clinical site. The trial will be conducted in the 11 primary care group practices participating in the TARGet Kids! research network in Canada. Eligible participants between the ages of 2–4 years will be randomly assigned to the intervention arm of regular xylitol syrup use or the control arm of regular sorbitol use for 6 months. We expect to recruit 236 participants, per treatment arm, to detect a 20% relative risk reduction in AOM episodes. AOM will be identified through chart review. The secondary outcomes of URTIs and dental caries will be identified through monthly phone calls with specified questions.Ethics and disseminationEthics approval from the Research Ethics Boards at the Hospital for Sick Children and St. Michael’s Hospital has been obtained for this study and also for the TARGet Kids! research network. Results will be submitted for publication to a peer-reviewed journal and will be discussed with decision makers.Trial registration number NCT03055091; Pre-results.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>30082349</pmid><doi>10.1136/bmjopen-2017-020941</doi><oa>free_for_read</oa></addata></record> |
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| source | BMJ Open Access Journals; MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; PubMed Central Open Access |
| subjects | Age Antibiotics Canada Caregivers Child, Preschool Cost analysis Dental caries Ear diseases Evidence-based medicine General practice / Family practice Humans Illnesses Medical screening Multicenter Studies as Topic Otitis Media - prevention & control Parents & parenting Pediatrics Pragmatic Clinical Trials as Topic Prevention Primary care Public health Respiratory diseases Streptococcus infections Sweetening Agents - therapeutic use Xylitol - therapeutic use |
| title | Xylitol for the prevention of acute otitis media episodes in children aged 2–4 years: protocol for a pragmatic randomised controlled trial |
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