{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T16:48:47Z","timestamp":1785775727429,"version":"3.56.0"},"reference-count":41,"publisher":"MDPI AG","issue":"8","license":[{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pathogens"],"abstract":"<jats:p>Background: Nirsevimab, a long-acting monoclonal antibody targeting respiratory syncytial virus (RSV), has recently been introduced as universal prophylaxis in newborns and infants. Although clinical trials have shown high efficacy and a favorable safety profile, real-world evidence remains limited. Objectives: Our Italian multicenter observational study included newborns eligible for nirsevimab prophylaxis during the 2025\u20132026 season and aimed to assess nirsevimab coverage, timing of administration, and short-term safety in routine clinical practice. The association between perinatal and environmental factors and neonatal intensive care unit (NICU) admission was also investigated, while RSV occurrence was evaluated as a descriptive and exploratory outcome. Methods: Eligible newborns were from four Italian hospitals during the 2025\u20132026 RSV season. We assessed nirsevimab coverage, timing of administration, RSV incidence, adverse events, and selected neonatal, perinatal, and maternal risk factors. Results: Among 1554 eligible newborns, 1462 received nirsevimab, corresponding to a coverage rate of 94.0%. The median age at administration was 3.0 days (IQR 2-6 days), with significantly delayed prophylaxis in preterm compared with term infants. During the observation period, two laboratory-confirmed RSV-associated bronchiolitis cases occurred, corresponding to a cumulative incidence of 0.13%. One case occurred in the immunized group and one in the non-immunized group. No adverse events following immunization were recorded. Conclusions: Nirsevimab prophylaxis achieved high coverage and showed a reassuring short-term safety profile in this real-world multicenter cohort. RSV infections were uncommon, and their very limited number prevents definitive conclusions regarding comparative effectiveness between immunized and non-immunized newborns. Prematurity was associated with delayed administration and greater need for intensive care, underscoring the importance of timely prophylaxis in vulnerable newborns.<\/jats:p>","DOI":"10.3390\/pathogens15080813","type":"journal-article","created":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T15:51:23Z","timestamp":1785772283000},"page":"813","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Coverage, Timing, Safety, and Determinants of Neonatal Intensive Care Unit Admission in Newborns Receiving Nirsevimab Prophylaxis for Respiratory Syncytial Virus"],"prefix":"10.3390","volume":"15","author":[{"given":"Maria","family":"Costantino","sequence":"first","affiliation":[{"name":"Department of Medicine, Surgery, and Dentistry, University of Salerno, 84081 Baronissi, Italy"},{"name":"University Hospital \u201cSan Giovanni di Dio e Ruggi d\u2019Aragona\u201d, 84131 Salerno, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7492-6848","authenticated-orcid":false,"given":"Valentina","family":"Giudice","sequence":"additional","affiliation":[{"name":"Department of Medicine, Surgery, and Dentistry, University of Salerno, 84081 Baronissi, Italy"},{"name":"University Hospital \u201cSan Giovanni di Dio e Ruggi d\u2019Aragona\u201d, 84131 Salerno, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna Maria","family":"Della Corte","sequence":"additional","affiliation":[{"name":"Department of Medicine, Surgery, and Dentistry, University of Salerno, 84081 Baronissi, Italy"},{"name":"University Hospital \u201cSan Giovanni di Dio e Ruggi d\u2019Aragona\u201d, 84131 Salerno, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvia","family":"Pecoraro","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, Sofia University \u201cSt. Kliment Ohridski\u201d, 1407 Sofia, Bulgaria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna Rita","family":"Frascogna","sequence":"additional","affiliation":[{"name":"University Hospital \u201cSan Giovanni di Dio e Ruggi d\u2019Aragona\u201d, 84131 Salerno, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Marchesano","sequence":"additional","affiliation":[{"name":"Neonatal Intensive Care and Neonatology Unit (U.O.S.D.), Department of Emergency and Acceptance (DEA), Umberto I Hospital, Nocera Inferiore\u2013Pagani\u2013Scafati, Salerno Local Health Authority (ASL Salerno), 84014 Nocera Inferiore, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabino","family":"Moschella","sequence":"additional","affiliation":[{"name":"Department of Neonatology and Neonatal Intensive Care Unit, San Giuseppe Moscati Hospital, 83100 Avellino, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carmela","family":"Alfano","sequence":"additional","affiliation":[{"name":"Department of Neonatology and Neonatal Intensive Care Unit, San Giuseppe Moscati Hospital, 83100 Avellino, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federica","family":"Santaniello","sequence":"additional","affiliation":[{"name":"Department of Pediatrics and Neonatology (UOC), Martiri Villa Malta Hospital, Salerno Local Health Authority (ASL Salerno), 84087 Sarno, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carmine","family":"Brengola","sequence":"additional","affiliation":[{"name":"Department of Pediatrics and Neonatology (UOC), Martiri Villa Malta Hospital, Salerno Local Health Authority (ASL Salerno), 84087 Sarno, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppina","family":"Napoletano","sequence":"additional","affiliation":[{"name":"Department of Pediatrics and Neonatology (UOC), Martiri Villa Malta Hospital, Salerno Local Health Authority (ASL Salerno), 84087 Sarno, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Virginia","family":"Caputo","sequence":"additional","affiliation":[{"name":"Neonatal Intensive Care and Neonatology Unit (U.O.S.D.), Department of Emergency and Acceptance (DEA), Umberto I Hospital, Nocera Inferiore\u2013Pagani\u2013Scafati, Salerno Local Health Authority (ASL Salerno), 84014 Nocera Inferiore, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Luciano","sequence":"additional","affiliation":[{"name":"Department of Medicine, Surgery, and Dentistry, University of Salerno, 84081 Baronissi, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Assunta","family":"Santullo","sequence":"additional","affiliation":[{"name":"University Hospital \u201cSan Giovanni di Dio e Ruggi d\u2019Aragona\u201d, 84131 Salerno, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6096-7497","authenticated-orcid":false,"given":"Luca","family":"Pierri","sequence":"additional","affiliation":[{"name":"Neonatal Intensive Care and Neonatology Unit, AORN\u2014IRCCS Santobono-Pausilipon Children\u2019s Hospital, 80129 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federica","family":"Aiello","sequence":"additional","affiliation":[{"name":"University Hospital \u201cSan Giovanni di Dio e Ruggi d\u2019Aragona\u201d, 84131 Salerno, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Carmen","family":"De Caro","sequence":"additional","affiliation":[{"name":"University Hospital \u201cSan Giovanni di Dio e Ruggi d\u2019Aragona\u201d, 84131 Salerno, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luciana","family":"Catena","sequence":"additional","affiliation":[{"name":"University Hospital \u201cSan Giovanni di Dio e Ruggi d\u2019Aragona\u201d, 84131 Salerno, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Concetta","family":"Sarnataro","sequence":"additional","affiliation":[{"name":"University Hospital \u201cSan Giovanni di Dio e Ruggi d\u2019Aragona\u201d, 84131 Salerno, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9659-9940","authenticated-orcid":false,"given":"Francesco","family":"De Caro","sequence":"additional","affiliation":[{"name":"Department of Medicine, Surgery, and Dentistry, University of Salerno, 84081 Baronissi, Italy"},{"name":"University Hospital \u201cSan Giovanni di Dio e Ruggi d\u2019Aragona\u201d, 84131 Salerno, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Grazia","family":"Corbo","sequence":"additional","affiliation":[{"name":"University Hospital \u201cSan Giovanni di Dio e Ruggi d\u2019Aragona\u201d, 84131 Salerno, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,8,1]]},"reference":[{"key":"ref_1","unstructured":"(2026, June 05). 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Dis."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"180","DOI":"10.1016\/S2352-4642(22)00321-2","article-title":"Efficacy of Nirsevimab against respiratory syncytial virus lower respiratory tract infections in preterm and term infants, and pharmacokinetic extrapolation to infants with congenital heart disease and chronic lung disease: A pooled analysis of randomized controlled trials","volume":"7","author":"Madhi","year":"2023","journal-title":"Lancet Child Adolesc. 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Open"},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"EVIDoa2400275","DOI":"10.1056\/EVIDoa2400275","article-title":"Nirsevimab Effectiveness at Preventing RSV-Related Hospitalization in Infants","volume":"4","author":"Jabagi","year":"2025","journal-title":"NEJM Evid."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"838","DOI":"10.1136\/thorax-2025-223376","article-title":"Real-world effectiveness and safety of nirsevimab, RSV maternal vaccine and RSV vaccines for older adults: A living systematic review and meta-analysis","volume":"80","author":"Lee","year":"2025","journal-title":"Thorax"},{"key":"ref_9","doi-asserted-by":"crossref","unstructured":"Costantino, M., Marongiu, M.B., Corbo, M.G., Della Corte, A.M., Frascogna, A.R., Plantulli, A., Campana, F., Fortino, L., Santoro, E., and Vozzella, E.A. (2025). Efficacy and Safety of Anti-Respiratory Syncytial Virus Monoclonal Antibody Nirsevimab in Neonates: A Real-World Monocentric Study. 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