{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,21]],"date-time":"2026-02-21T13:29:50Z","timestamp":1771680590568,"version":"3.50.1"},"reference-count":30,"publisher":"Oxford University Press (OUP)","issue":"11","license":[{"start":{"date-parts":[[2021,4,24]],"date-time":"2021-04-24T00:00:00Z","timestamp":1619222400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"DOI":"10.13039\/501100006197","name":"Fonden til L\u00e6gevidenskabens Fremme","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100006197","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Research Center for Vitamins and Vaccines"},{"DOI":"10.13039\/501100001732","name":"Danish National Research Foundation","doi-asserted-by":"publisher","award":["DNRF108"],"award-info":[{"award-number":["DNRF108"]}],"id":[{"id":"10.13039\/501100001732","id-type":"DOI","asserted-by":"publisher"}]},{"name":"CVIVA"},{"DOI":"10.13039\/501100006356","name":"University of Southern Denmark","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100006356","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001713","name":"EDCTP","doi-asserted-by":"publisher","award":["RIA2020EF-3049"],"award-info":[{"award-number":["RIA2020EF-3049"]}],"id":[{"id":"10.13039\/501100001713","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004191","name":"Novo Nordisk","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004191","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000781","name":"European Research Council","doi-asserted-by":"publisher","award":["ERC-2009-StG-243149"],"award-info":[{"award-number":["ERC-2009-StG-243149"]}],"id":[{"id":"10.13039\/501100000781","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,12,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Randomized controlled trials (RCTs) indicate that bacille Calmette-Gu\u00e9rin (BCG) vaccination provides broad beneficial \u201cnonspecific\u201d protection against infections. We investigated the effect on in-hospital mortality of providing BCG immediately upon admission to a neonatal intensive care unit (NICU), rather than BCG-at-discharge. The pretrial NICU mortality was 13% and we hypothesized that BCG would reduce mortality by 40%.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Parallel-group, open-label RCT was initiated in 2013 in Guinea-Bissau. Neonatal intensive care unit-admitted neonates were randomized 1:1 to BCG\u2005+\u2005oral polio vaccine (OPV) immediately (intervention) versus BCG\u2005+\u2005OPV at hospital discharge (control; usual practice). The trial was discontinued due to decreasing in-hospital mortality and major NICU restructuring. We assessed overall and disease-specific mortality by randomization allocation in cox proportional hazards models providing mortality rate ratios (MRRs).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>We recruited 3353 neonates, and the overall mortality was 3.1% (52 of 1676) for BCG-vaccinated neonates versus 3.3% (55 of 1677) for controls (MRR\u2005=\u20050.94; 0.64\u20131.36). For noninfectious causes of death, the MRR was 1.20 (0.70\u20132.07), and there tended to be fewer deaths from infections in the BCG group (N\u2005=\u200514) than among controls (N\u2005=\u200521) (MRR\u2005=\u20050.65; 0.33\u20131.28).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Providing BCG\u2005+\u2005OPV to frail neonates was safe and might protect against fatal infection in the immediate newborn period. Deaths due to prematurity and perinatal complications were unaffected by BCG.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/infdis\/jiab220","type":"journal-article","created":{"date-parts":[[2021,4,19]],"date-time":"2021-04-19T19:34:03Z","timestamp":1618860843000},"page":"1935-1944","source":"Crossref","is-referenced-by-count":17,"title":["Immediate Bacille Calmette-Gu\u00e9rin Vaccination to Neonates Requiring Perinatal Treatment at the Maternity Ward in Guinea-Bissau: A Randomized Controlled Trial"],"prefix":"10.1093","volume":"224","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7643-8322","authenticated-orcid":false,"given":"Frederik","family":"Schaltz-Buchholzer","sequence":"first","affiliation":[{"name":"Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau"},{"name":"Bandim Health Project, OPEN, Department of Clinical Research, University Southern Denmark and Odense University Hospital, Odense, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Aaby","sequence":"additional","affiliation":[{"name":"Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ivan","family":"Monteiro","sequence":"additional","affiliation":[{"name":"Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luis","family":"Camala","sequence":"additional","affiliation":[{"name":"Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Simone","family":"Faurholt Simonsen","sequence":"additional","affiliation":[{"name":"Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hannah","family":"N\u00f8rtoft Frankel","sequence":"additional","affiliation":[{"name":"Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kristina","family":"Lindberg Larsen","sequence":"additional","affiliation":[{"name":"Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian N","family":"Golding","sequence":"additional","affiliation":[{"name":"Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tobias R","family":"Kollmann","sequence":"additional","affiliation":[{"name":"Telethon Kids Institute, Subiaco, Australia"},{"name":"Department of Pediatrics, University of British Columbia, Vancouver, British Columbia, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nelly","family":"Amenyogbe","sequence":"additional","affiliation":[{"name":"Telethon Kids Institute, Subiaco, Australia"},{"name":"Department of Pediatrics, University of British Columbia, Vancouver, British Columbia, Canada"},{"name":"Department of Experimental Medicine, University of British Columbia, Vancouver, Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christine","family":"Stabell Benn","sequence":"additional","affiliation":[{"name":"Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau"},{"name":"Bandim Health Project, OPEN, Department of Clinical Research, University Southern Denmark and Odense University Hospital, Odense, Denmark"},{"name":"Danish Institute of Advanced Science, University Southern Denmark, Odense, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Morten","family":"Bjerregaard-Andersen","sequence":"additional","affiliation":[{"name":"Bandim Health Project, INDEPTH Network, Bissau, Guinea-Bissau"},{"name":"Department of Endocrinology, Hospital of Southwest Denmark, Esbjerg, Denmark"},{"name":"Steno Diabetes Center, Odense University Hospital, Odense, 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