{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,13]],"date-time":"2025-12-13T04:33:05Z","timestamp":1765600385796,"version":"3.48.0"},"reference-count":27,"publisher":"BMJ","issue":"7","license":[{"start":{"date-parts":[[2025,7,4]],"date-time":"2025-07-04T00:00:00Z","timestamp":1751587200000},"content-version":"unspecified","delay-in-days":3,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004562","name":"Minist\u00e8re de l\u2019Enseignement sup\u00e9rieur et de la Recherche","doi-asserted-by":"publisher","award":["PHRCI-19-011 - FINESS 750712184"],"award-info":[{"award-number":["PHRCI-19-011 - FINESS 750712184"]}],"id":[{"id":"10.13039\/501100004562","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,6,20]]},"published-print":{"date-parts":[[2025,7]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Severe perinatal asphyxia at term or near term remains a critical public health issue, associated with high risks of neonatal death and hypoxic-ischaemic encephalopathy (HIE). Despite improved clinical guidelines, suboptimal care persists in many cases, and previous audits have demonstrated that up to 50% of asphyxia cases could be associated with suboptimal care. OptiNeoCare is a French study which aims to assess the prevalence and determinants of suboptimal obstetric and neonatal care and evaluate its potential impact on neonatal outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and methods<\/jats:title>\n                    <jats:p>This prospective, population-based observational study will include newborns \u226536 weeks\u2019 gestation with severe perinatal asphyxia across 12 French perinatal networks (213 maternity units). Inclusion criteria comprise neonatal death or moderate\/severe HIE with confirmed biochemical markers of asphyxia. Data will be collected prospectively from labour wards, transport teams and neonatal intensive care units using an electronic case report form, and the in-situ team will be invited to complete a morbi-mortality review (MMR). Approximately 336 cases will be included over 12 months, with 25% randomly selected for confidential enquiry by two experts. The quality of care will be assessed based on a structured classification of medical errors (diagnostic, therapeutic, preventive and systemic) by a panel of experts including an obstetrician or midwife and a paediatrician. Root cause analysis will identify determinants of suboptimal care. A concordance analysis will compare findings from MMRs and confidential enquiries. Statistical analysis will include multivariable logistic regression to explore associations between care quality and neonatal outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethical approval was granted by the Ethics Committee for Research in Obstetrics and Gynaecology. Informed non-opposition is required from participants. Results will be shared with participating centres, healthcare professionals and through scientific dissemination.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov ID:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06322732\">NCT06322732<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-106093","type":"journal-article","created":{"date-parts":[[2025,7,5]],"date-time":"2025-07-05T09:45:29Z","timestamp":1751708729000},"page":"e106093","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["OptiNeoCare: optimisation of routine care in the management of severe perinatal asphyxia in full-term or near-term newborns \u2013 study protocol for analysis of suboptimal care by confidential inquiries and e-self report"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct06322732","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06322732","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6330-5085","authenticated-orcid":false,"given":"Isabelle","family":"Guellec","sequence":"first","affiliation":[{"name":"Department of Medicine, Nice C\u00f4te d\u2019Azur University, Nice, France"},{"name":"Department of Neonatal Intensive Care, University Hospital Centre Nice, Nice, France"},{"name":"OPPaLE (Obstetric, perinatal, paediatric life course epidemiology), INSERM UMR 1153, Paris, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pierre-Yves","family":"Ancel","sequence":"additional","affiliation":[{"name":"OPPaLE (Obstetric, perinatal, paediatric life course epidemiology), INSERM UMR 1153, Paris, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hendy","family":"Abdoul","sequence":"additional","affiliation":[{"name":"URC Paris Descartes Necker\/Cochin, Assistance Publique - Hopitaux de Paris, Paris, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charles","family":"Garabedian","sequence":"additional","affiliation":[{"name":"Department of Obstetrics, ULR 2694-METRICS, CHU Lille, University of Lille, Lille, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eric","family":"Verspyck","sequence":"additional","affiliation":[{"name":"Rouen Univ Hosp, Rouen, France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cyril","family":"Huissoud","sequence":"additional","affiliation":[{"name":"Croix Rousse University Hospital, Lyon, 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