{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,28]],"date-time":"2025-10-28T15:10:26Z","timestamp":1761664226859,"version":"build-2065373602"},"reference-count":23,"publisher":"BMJ","issue":"4","license":[{"start":{"date-parts":[[2021,4,6]],"date-time":"2021-04-06T00:00:00Z","timestamp":1617667200000},"content-version":"unspecified","delay-in-days":5,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000272","name":"National Institute for Health Research","doi-asserted-by":"crossref","award":["NIHR201173"],"award-info":[{"award-number":["NIHR201173"]}],"id":[{"id":"10.13039\/501100000272","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2021,3,17]]},"published-print":{"date-parts":[[2021,4]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>The craniofacial abnormalities found in infants with cleft palate (CP) decrease their airway patency and increase their risk of obstructive sleep apnoea (OSA). We hypothesise that optimising sleep position in infants with CP may improve airway patency and offer a \u2018low-cost, high-impact\u2019 intervention to prevent the negative impacts of OSA. Because cleft centres give inconsistent advice about sleep position: some recommend back-lying and others side-lying, we will compare these in a randomised controlled trial.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>The aim is to determine the clinical effectiveness of side-lying as compared with back-lying sleep positioning in terms of reducing oxygen desaturation resulting from OSA in 244 infants aged 3\u20135 weeks of age, diagnosed with an isolated CP in\/by UK cleft centres. Primary outcome is the 4% Oxygen Desaturation Index measured using pulse oximetry during sleep.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Research plan<\/jats:title>\n                  <jats:p>1. Multicentre randomised controlled trial of side-lying compared with back-lying sleep positioning in reducing oxygen desaturation resulting from OSA in infants with CP at one month of age. 2. Internal pilot questionnaire-based study to support parents and clinicians regarding study participation, seeking to identify and address any barriers to recruitment. Monitoring data from the internal pilot will be used in the final analysis. 3. Co-development of new UK recommendations with Cleft Lip and Palate Association (CLAPA) regarding sleep position for infants with CP.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>The study protocol has received the favourable opinion of the West Midlands-South Birmingham Research Ethics Committee. Study results will be published on affiliated webpages and in peer-reviewed publications and conference contributions.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>\n                     <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04478201\">NCT04478201<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2021-049290","type":"journal-article","created":{"date-parts":[[2021,4,7]],"date-time":"2021-04-07T14:40:42Z","timestamp":1617806442000},"page":"e049290","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Study protocol for randomised clinical trial comparing the effectiveness of side-lying sleep positioning to back-lying at reducing oxygen desaturation resulting from obstructive sleep apnoea in infants with cleft palate (SLUMBRS2)"],"prefix":"10.1136","volume":"11","clinical-trial-number":[{"clinical-trial-number":"nct04478201","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9871-5167","authenticated-orcid":false,"given":"Aleksandra","family":"Metryka","sequence":"first","affiliation":[{"name":"Research and Innovation, Manchester University NHS Foundation Trust, Manchester, Manchester, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claire","family":"Cunniffe","sequence":"additional","affiliation":[{"name":"Cleft Lip and Palate Association (CLAPA), London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hazel J","family":"Evans","sequence":"additional","affiliation":[{"name":"Department of Respiratory Paediatrics, Southampton Children\"s Hospital, Southampton, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Johanna G","family":"Gavlak","sequence":"additional","affiliation":[{"name":"Department of Respiratory Paediatrics, Southampton Children\"s Hospital, Southampton, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nichola","family":"Hudson","sequence":"additional","affiliation":[{"name":"Salisbury NHS Foundation Trust, Salisbury, Wiltshire, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nigel","family":"Kirby","sequence":"additional","affiliation":[{"name":"Centre for Trials Research, Cardiff University, Cardiff, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5288-3325","authenticated-orcid":false,"given":"Monica","family":"Lakhanpaul","sequence":"additional","affiliation":[{"name":"Policy & Practice Department, UCL Great Ormond Street Institute of Child Health Population Policy and Practice, London, UK"},{"name":"Community Paediatrics, Whittington Health NHS Trust, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yin-Ling","family":"Lin","sequence":"additional","affiliation":[{"name":"School of Dentistry, The University of Manchester, Manchester, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Clare","family":"Murray","sequence":"additional","affiliation":[{"name":"Royal Manchester Children\u2019s Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK"},{"name":"Division of Infection, Immunity and Respiratory Medicine, The University of Manchester Faculty of Biology Medicine and Health, Manchester, Manchester, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Azita","family":"Rajai","sequence":"additional","affiliation":[{"name":"Research and Innovation, Manchester University NHS Foundation Trust, Manchester, Manchester, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helen","family":"Robson","sequence":"additional","affiliation":[{"name":"Royal Manchester Children\u2019s Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne","family":"Schilder","sequence":"additional","affiliation":[{"name":"evidENT, UCL Ear Institute, London, UK"},{"name":"NIHR University College London Hospitals Biomedical Research Centre, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tanya","family":"Walsh","sequence":"additional","affiliation":[{"name":"School of Dentistry, The University of Manchester, Manchester, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Iain","family":"Bruce","sequence":"additional","affiliation":[{"name":"Royal Manchester Children\u2019s Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK"},{"name":"Division of Infection, Immunity and Respiratory Medicine, The University of Manchester Faculty of Biology Medicine and Health, Manchester, Manchester, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2021,4,7]]},"reference":[{"key":"2025101814504499000_11.4.e049290.1","doi-asserted-by":"crossref","first-page":"189","DOI":"10.1067\/mod.2002.125234","article-title":"Comparison of the sizes of adenoidal tissues and upper airways of subjects with and without cleft lip and palate","volume":"122","author":"Imamura","year":"2002","journal-title":"Am J Orthod Dentofacial Orthop"},{"key":"2025101814504499000_11.4.e049290.2","doi-asserted-by":"publisher","DOI":"10.1136\/archdischild-2012-302104"},{"key":"2025101814504499000_11.4.e049290.3","doi-asserted-by":"publisher","DOI":"10.1002\/ppul.20763"},{"key":"2025101814504499000_11.4.e049290.4","doi-asserted-by":"publisher","DOI":"10.1597\/07-215.1"},{"key":"2025101814504499000_11.4.e049290.5","doi-asserted-by":"publisher","DOI":"10.1016\/j.sleep.2005.11.003"},{"key":"2025101814504499000_11.4.e049290.6","doi-asserted-by":"publisher","DOI":"10.1080\/080352500300002444"},{"key":"2025101814504499000_11.4.e049290.7","doi-asserted-by":"publisher","DOI":"10.1054\/bjps.2001.3618"},{"key":"2025101814504499000_11.4.e049290.8","doi-asserted-by":"crossref","first-page":"189","DOI":"10.1016\/j.cps.2013.12.005","article-title":"Cleft palate repair","volume":"41","author":"Smith","year":"2014","journal-title":"Clin Plast Surg"},{"key":"2025101814504499000_11.4.e049290.9","doi-asserted-by":"crossref","first-page":"661","DOI":"10.1007\/s00431-017-2893-0","article-title":"Safe sleeping positions: practice and policy for babies with cleft palate","volume":"176","author":"Davies","year":"2017","journal-title":"Eur J Pediatr"},{"key":"2025101814504499000_11.4.e049290.10","doi-asserted-by":"publisher","DOI":"10.1097\/MLG.0b013e31815667f3"},{"key":"2025101814504499000_11.4.e049290.11","doi-asserted-by":"publisher","DOI":"10.1213\/01.ANE.0000148126.53015.F9"},{"key":"2025101814504499000_11.4.e049290.12","doi-asserted-by":"crossref","first-page":"1638","DOI":"10.1213\/01.ANE.0000135637.95853.1C","article-title":"The effects of chin lift and jaw thrust while in the lateral position on stridor score in anesthetized children with adenotonsillar hypertrophy","volume":"99","author":"Arai","year":"2004","journal-title":"Anesth Analg"},{"key":"2025101814504499000_11.4.e049290.13","doi-asserted-by":"publisher","DOI":"10.1213\/01.ane.0000262041.46833.21"},{"key":"2025101814504499000_11.4.e049290.14","doi-asserted-by":"publisher","DOI":"10.1097\/00000542-200509000-00009"},{"key":"2025101814504499000_11.4.e049290.15","doi-asserted-by":"crossref","unstructured":"Ahmed MK , Bui AH , Taioli E . Designing strategies for cleft lip and palate care, 2016.","DOI":"10.5772\/67165"},{"key":"2025101814504499000_11.4.e049290.16","unstructured":"CRANE database - Home 2019. Available: https:\/\/www.crane-database.org.uk\/ [Accessed 09 July 2019]."},{"key":"2025101814504499000_11.4.e049290.17","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.e7586"},{"key":"2025101814504499000_11.4.e049290.18","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2010.03.004"},{"key":"2025101814504499000_11.4.e049290.19","doi-asserted-by":"crossref","first-page":"222","DOI":"10.1177\/1055665618770196","article-title":"Parental experience of sleep-disordered breathing in infants with cleft palate: comparing parental and clinical priorities","volume":"56","author":"Davies","year":"2019","journal-title":"Cleft Palate Craniofac J"},{"key":"2025101814504499000_11.4.e049290.20","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3476(99)70056-9"},{"key":"2025101814504499000_11.4.e049290.21","doi-asserted-by":"crossref","unstructured":"Murray CS et al . Does sleep position influence sleep disordered breathing in infants with cleft palate: a feasibility study? The Cleft Palate-Craniofacial Journal 2020.","DOI":"10.1177\/10556656211003459"},{"key":"2025101814504499000_11.4.e049290.22","doi-asserted-by":"publisher","DOI":"10.1136\/archdischild-2017-314361"},{"key":"2025101814504499000_11.4.e049290.23","doi-asserted-by":"publisher","DOI":"10.1111\/jpc.14586"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2021-049290","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,18]],"date-time":"2025-10-18T21:50:55Z","timestamp":1760824255000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2021-049290"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,4]]},"references-count":23,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2021,4,7]]},"published-print":{"date-parts":[[2021,4]]}},"alternative-id":["10.1136\/bmjopen-2021-049290"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2021-049290","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"type":"print","value":"2044-6055"},{"type":"electronic","value":"2044-6055"}],"subject":[],"published":{"date-parts":[[2021,4]]}}}