{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T11:59:43Z","timestamp":1785326383776,"version":"3.55.0"},"reference-count":11,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T00:00:00Z","timestamp":1785283200000},"content-version":"unspecified","delay-in-days":28,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000265","name":"Medical Research Council","doi-asserted-by":"publisher","award":["MRC\/IAA 2021 - MR\/X502728\/1"],"award-info":[{"award-number":["MRC\/IAA 2021 - MR\/X502728\/1"]}],"id":[{"id":"10.13039\/501100000265","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open Resp Res"],"accepted":{"date-parts":[[2026,6,24]]},"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>Use of long-term non-invasive ventilation (NIV) for children is increasing. Standard masks often fit poorly, causing significant complications. This pilot study aimed to evaluate a customised NIV mask\/headgear.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>The evaluation took place in a single tertiary care centre.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>Five children aged 2\u201315 years using NIV for respiratory support and for whom a well-fitting commercial mask could not be found completed the study. Those requiring ventilation for rescue breaths or supplementary oxygen were excluded.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Intervention<\/jats:title>\n                    <jats:p>Each participant received a 3D-designed NIV mask and headgear, customised to the individual using 3D scanning and computer-aided design. The custom mask and headgear were compared with the child\u2019s usual mask and headgear for two nights each.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Primary and secondary outcome measures<\/jats:title>\n                    <jats:p>\n                      The primary outcome measure was comfort, measured using a 7-point Likert scale; secondary outcome measures were facial skin marks, measured using a diary card; ventilator efficacy, measured by 4% oxygen desaturation index (ODI\n                      <jats:sub>4<\/jats:sub>\n                      ) and sleep quality, measured by actigraphy recordings of overnight \u2018Actual Wake\u2019.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Compared with the usual mask\/headgear, the median discomfort score using the custom mask\/headgear reduced from 5 Likert points (IQR 0) to 3 (IQR 2), and facial skin sores reduced from 1.5 (IQR 3) to 1 (IQR 0). Median Oxygen Desaturation Index (ODI\n                      <jats:sub>4<\/jats:sub>\n                      ) was similar: 0.76 (IQR 0.8) with standard mask\/headgear and 0.77 (IQR 0.71) with the custom mask\/headgear and median Actual Wake % was 2.95 (IQR 2.31) with standard mask\/headgear and 3.70 (IQR 4.85) with the custom mask\/headgear.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Customisation of NIV masks and headgear using 3D printing may provide a valuable solution for children for whom a well-fitting commercial mask cannot be found. A multicentre study will seek to clarify definitive outcomes.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjresp-2025-003770","type":"journal-article","created":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T11:05:15Z","timestamp":1785323115000},"page":"e003770","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Pilot evaluation of 3D-designed custom-made integrated mask and headgear for children using non-invasive ventilation"],"prefix":"10.1136","volume":"13","author":[{"given":"Mollie","family":"Broadbent","sequence":"first","affiliation":[{"name":"University of Sheffield, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Shortland","sequence":"additional","affiliation":[{"name":"Sheffield Children\u2019s NHS Foundation Trust, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matt","family":"Willox","sequence":"additional","affiliation":[{"name":"Design Futures, Sheffield Hallam University, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Metherall","sequence":"additional","affiliation":[{"name":"Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacob","family":"Branchflower","sequence":"additional","affiliation":[{"name":"Health-Tech Research Centre for Children and Young People, NIHR, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vanessa E","family":"Craven","sequence":"additional","affiliation":[{"name":"Sheffield Children\u2019s NHS Foundation Trust, Sheffield, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8982-9250","authenticated-orcid":false,"given":"Heather E","family":"Elphick","sequence":"additional","affiliation":[{"name":"Sheffield Children\u2019s NHS Foundation Trust, Sheffield, UK"},{"name":"Health-Tech Research Centre for Children and Young People, NIHR, London, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,7,29]]},"reference":[{"key":"2026072904051240000_13.1.e003770.1","doi-asserted-by":"publisher","DOI":"10.1136\/archdischild-2021-323562"},{"key":"2026072904051240000_13.1.e003770.2","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0125839","article-title":"Long term non-invasive ventilation in children: impact on survival and transition to adult care","volume":"10","author":"Chatwin","year":"2015","journal-title":"PLoS One"},{"key":"2026072904051240000_13.1.e003770.3","doi-asserted-by":"publisher","DOI":"10.1136\/adc.2002.018655"},{"key":"2026072904051240000_13.1.e003770.4","first-page":"409","article-title":"Investigating the effects of strap tension during non-invasive ventilation mask application: a combined biomechanical and biomarker approach","volume":"9","author":"Worsley","year":"2016","journal-title":"Med Devices (Auckl)"},{"key":"2026072904051240000_13.1.e003770.5","doi-asserted-by":"publisher","DOI":"10.1007\/s00134-005-2669-2"},{"key":"2026072904051240000_13.1.e003770.6","article-title":"O10 3D-designed custom-made modular headgear for Children using non-invasive ventilation. [The \u2018COMFORT\u2019 project: Custom-Made Facemasks for Respiratory Therapy]","volume":"10","author":"Willox","year":"2023","journal-title":"BMJ Open Respir Res"},{"key":"2026072904051240000_13.1.e003770.7","doi-asserted-by":"publisher","DOI":"10.4187\/respcare.11886"},{"key":"2026072904051240000_13.1.e003770.8","doi-asserted-by":"crossref","first-page":"213","DOI":"10.1080\/03091902.2020.1769759","article-title":"Custom-made 3D printed masks for children using non-invasive ventilation: a feasibility study of production method and testing of outcomes in adult volunteers","volume":"44","author":"Willox","year":"2020","journal-title":"J Med Eng Technol"},{"key":"2026072904051240000_13.1.e003770.9","doi-asserted-by":"crossref","first-page":"627","DOI":"10.18063\/ijb.v9i1.627","article-title":"Feasibility of three-dimensional nasal imaging and printing in producing customized nasal masks for non-invasive ventilation in extremely low birth weight infant: A pilot study","volume":"9","author":"Mart\u00edn-G\u00f3nz\u00e1lez","year":"2022","journal-title":"Int J Bioprint"},{"key":"2026072904051240000_13.1.e003770.10","doi-asserted-by":"crossref","DOI":"10.1164\/rccm.201407-1357IM","article-title":"Three-dimensional modeled custom-made noninvasive positive pressure ventilation masks in an infant","volume":"190","author":"Carroll","year":"2014","journal-title":"Am J Respir Crit Care Med"},{"key":"2026072904051240000_13.1.e003770.11","doi-asserted-by":"crossref","first-page":"106608","DOI":"10.1016\/j.sleep.2025.106608","article-title":"Development of an individualized and functional CPAP ventilation mask using a fully digital workflow by facial scanning and additive manufacturing for a child with craniofacial anomalies","volume":"133","author":"Bockstedte","year":"2025","journal-title":"Sleep Med"}],"container-title":["BMJ Open Respiratory Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjresp-2025-003770","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T11:05:17Z","timestamp":1785323117000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopenrespres.bmj.com\/lookup\/doi\/10.1136\/bmjresp-2025-003770"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7]]},"references-count":11,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,7,29]]},"published-print":{"date-parts":[[2026,7]]}},"alternative-id":["10.1136\/bmjresp-2025-003770"],"URL":"https:\/\/doi.org\/10.1136\/bmjresp-2025-003770","relation":{},"ISSN":["2052-4439"],"issn-type":[{"value":"2052-4439","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7]]}}}