{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T03:06:37Z","timestamp":1791601597875,"version":"4.3.4"},"reference-count":34,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2025,4,29]],"date-time":"2025-04-29T00:00:00Z","timestamp":1745884800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,4,29]],"date-time":"2025-04-29T00:00:00Z","timestamp":1745884800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100001826","name":"ZonMw","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001826","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100008873","name":"European Society for Paediatric Research","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100008873","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["BJOG"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Artificial Amnion and Placenta Technology (AAPT), designed to improve outcomes in extreme prematurity, has shown promise in animal studies, with human trials anticipated soon. This study seeks to inform the responsible design of future trials by utilising insights from parents who experienced an (imminent) extremely premature birth and perinatal healthcare professionals (HCPs).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>A qualitative study using individual and focus group interviews.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>This study was part of a Dutch study called Toward Individualised care of the Youngest.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Sample<\/jats:title>\n                    <jats:p>Fifteen parents who experienced an (imminent) extremely premature birth and 46 HCPs were interviewed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Eight focus\u2010group and five individual interviews were performed and transcribed. The transcripts were thematically analysed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main Outcomes and Measures<\/jats:title>\n                    <jats:p>The perspectives of HCPs and experienced parents on what they considered essential for human AAPT trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Analyses revealed some critical considerations represented in six themes: (1) optimise the animal model, (2) determine the goal of human trials, (3) carefully establish the research population, (4) formulate stop criteria, success criteria and outcome measures, (5) determine the role for parents during the AAPT trial, and (6) develop protocols for the trial and address logistical considerations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This study emphasises the critical role of stakeholder involvement in safeguarding the responsible design of human AAPT trials. Defining the trial objectives including well\u2010defined stop criteria and follow\u2010up schemes is a key element for the human AAPT trials. Establishing consensus among stakeholders is essential, as shared recommendations will facilitate alignment of expectations and promote engagement.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/1471-0528.18189","type":"journal-article","created":{"date-parts":[[2025,4,30]],"date-time":"2025-04-30T00:30:18Z","timestamp":1745973018000},"page":"1574-1583","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Stakeholder Perspectives on the Design of First\u2010In\u2010Human Trials for Artificial Amnion and Placenta Technology: A Qualitative Study"],"prefix":"10.1111","volume":"132","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8281-5873","authenticated-orcid":false,"given":"Angret","family":"de Boer","sequence":"first","affiliation":[{"name":"Department of Obstetrics Leiden University Medical Center  Leiden the Netherlands"},{"name":"Department of Neonatology Radboudumc Amalia Children's Hospital  Nijmegen the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6524-184X","authenticated-orcid":false,"given":"Andr\u00e9","family":"Krom","sequence":"additional","affiliation":[{"name":"Department of Medical Ethics and Health law Leiden University Medical Center  Leiden the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rania","family":"Kalaai","sequence":"additional","affiliation":[{"name":"Department of Neonatology Radboudumc Amalia Children's Hospital  Nijmegen the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marieke","family":"de Vries","sequence":"additional","affiliation":[{"name":"Institute for Computing and Information Sciences (iCIS) Radboud University  Nijmegen the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2562-7606","authenticated-orcid":false,"given":"Marije","family":"Hogeveen","sequence":"additional","affiliation":[{"name":"Department of Neonatology Radboudumc Amalia Children's Hospital  Nijmegen the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-8886-6892","authenticated-orcid":false,"given":"Sylvia A.","family":"Obermann\u2010Borst","sequence":"additional","affiliation":[{"name":"Care4Neo, Neonatal Patient and Parent Advocacy Organization  Rotterdam the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9686-8186","authenticated-orcid":false,"given":"Marijn","family":"Vermeulen","sequence":"additional","affiliation":[{"name":"Department of Neonatal and Pediatric Intensive Care, Division of Neonatology Sophia Children's Hospital  Rotterdam the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5805-5333","authenticated-orcid":false,"given":"M. Beatrijs","family":"van der Hout\u2010van der Jagt","sequence":"additional","affiliation":[{"name":"Department of Obstetrics &amp; Gynecology M\u00e1xima Medisch Centrum  Veldhoven the Netherlands"},{"name":"Departments of Electrical Engineering and Biomedical Engineering Eindhoven University of Technology  Eindhoven the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2878-7349","authenticated-orcid":false,"given":"Juliette S.","family":"van Haren","sequence":"additional","affiliation":[{"name":"Department of Industrial Design Eindhoven University of Technology  Eindhoven the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5159-6874","authenticated-orcid":false,"given":"Peter","family":"Andriessen","sequence":"additional","affiliation":[{"name":"Department of Neonatology M\u00e1xima Medical Center  Veldhoven the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3178-7470","authenticated-orcid":false,"given":"Martine C.","family":"de Vries","sequence":"additional","affiliation":[{"name":"Department of Medical Ethics and Health law Leiden University Medical Center  Leiden the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5640-6160","authenticated-orcid":false,"given":"Rosa","family":"Geurtzen","sequence":"additional","affiliation":[{"name":"Department of Neonatology Radboudumc Amalia Children's Hospital  Nijmegen the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9343-9957","authenticated-orcid":false,"given":"E. J. T.","family":"Verweij","sequence":"additional","affiliation":[{"name":"Department of Obstetrics Leiden University Medical Center  Leiden the Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,4,29]]},"reference":[{"key":"e_1_2_11_2_1","unstructured":"World Health Organization \u201cPreterm Birth Factsheet 2023 \u201dhttps:\/\/www.who.int\/news\u2010room\/fact\u2010sheets\/detail\/preterm\u2010birth."},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2018-0933"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/ncomms15112"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/pd.5821"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/MAT.0000000000000939"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.21037\/tp-20-136"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1038\/d41586-023-02901-1"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/bioe.12701"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41372-023-01753-x"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3468(98)90085-9"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41372-023-01713-5"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.3389\/fped.2021.793308"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.semperi.2021.151521"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1177\/17470161241259127"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.3389\/fped.2021.793531"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1136\/archdischild\u20102024\u2010327400"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1136\/archdischild\u20102023\u2010325997"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1111\/apa.16866"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1136\/archdischild\u20102024\u2010327398"},{"key":"e_1_2_11_21_1","first-page":"64","volume-title":"Guidance Ethics Approach: An Ethical Dialogue About Technology With Perspective on Actions","author":"Verbeek P.\u2010P.","year":"2020"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1080\/15265161.2023.2191028"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.3402\/qhw.v9.26152"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1080\/15265161.2022.2048738"},{"key":"e_1_2_11_25_1","unstructured":"EUR\u2010Lex \u201cRegulation (EU) No 536\/2014 of the European Parliament and of the Council of 16 April 2014 on Clinical Trials on Medicinal Products for Human Use and Repealing Directive 2001\/20\/EC Text With EEA Relevance \u201d (2014)."},{"key":"e_1_2_11_26_1","unstructured":"European Medicines Agency \u201cICH E6 (R2) Good Clinical Practice\u2014Scientific Guideline \u201d (2016)."},{"key":"e_1_2_11_27_1","unstructured":"US Department of Health and Human Services \u201cFederal Policy for the Protection of Human Subjects (\u2018Common Rule\u2019) \u201d (2018)."},{"key":"e_1_2_11_28_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.12582"},{"key":"e_1_2_11_29_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1748-720X.2009.00349.x"},{"key":"e_1_2_11_30_1","doi-asserted-by":"publisher","DOI":"10.1097\/DCC.0000000000000186"},{"key":"e_1_2_11_31_1","doi-asserted-by":"publisher","DOI":"10.1093\/pch\/pxy158"},{"key":"e_1_2_11_32_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2015\u20102336"},{"key":"e_1_2_11_33_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.siny.2017.09.003"},{"key":"e_1_2_11_34_1","unstructured":"A.deBoer A.Krom R.Kalaai et\u00a0al. \u201cHealthcare Professionals' and Parental Perspectives on Human Artificial Placenta Technology\u2010Trials: Counselling and Informed Consent \u201d (2024)."},{"key":"e_1_2_11_35_1","doi-asserted-by":"publisher","DOI":"10.3389\/fped.2021.634290"}],"container-title":["BJOG: An International Journal of Obstetrics &amp; Gynaecology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1471-0528.18189","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/1471-0528.18189","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1471-0528.18189","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,30]],"date-time":"2026-01-30T02:38:27Z","timestamp":1769740707000},"score":1,"resource":{"primary":{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/10.1111\/1471-0528.18189"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,4,29]]},"references-count":34,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2025,10]]}},"alternative-id":["10.1111\/1471-0528.18189"],"URL":"https:\/\/doi.org\/10.1111\/1471-0528.18189","archive":["Portico"],"relation":{},"ISSN":["1470-0328","1471-0528"],"issn-type":[{"value":"1470-0328","type":"print"},{"value":"1471-0528","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,4,29]]},"assertion":[{"value":"2024-12-12","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-04-07","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-04-29","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}