Evidence map›Paper›PMID 42797813›Full record

Observational studyViruses2026

Real-World Effectiveness of Nirsevimab Against RSV-LRTI and Bronchiolitis Hospitalization: Results from the 2024-2025 Italian Universal Immunization Campaign in Newborns.

Cinzia Auriti, Camilla Gizzi, Matteo Riccò, Roberto Bellù, Mario Giuffrè, Adele Fabiano, Caterina Cacace, Paola Cavicchioli, Armando Cuttano, Susanna Di Valerio and 12 more

Abstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Viruses, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Cinzia AuritiFaculty of Medicine, General and Specialist Pediatrics, Saint Camillus International University of Health and Medical Sciences (Unicamillus), 00131 Rome, Italy.ORCID 0000-0001-9820-6557
Camilla GizziNeonatal Intensive Care Unit S., Eugenio Hospital, 00144 Rome, Italy.ORCID 0000-0003-3305-7014
Matteo RiccòServizio di Prevenzione e Sicurezza Negli Ambienti di Lavoro (SPSAL), AUSL-IRCCS di Reggio Emilia, 42122 Reggio Emilia, Italy.ORCID 0000-0002-6525-2159
Roberto BellùNeonatal Intensive Care and Neonatal Units, Lecco Hospital of Lecco ASST, 23900 Lecco, Italy.
Mario GiuffrèNeonatal Intensive Care Unit and Pediatrics, G. D'Alessandro Department, Palermo University, 90127 Palermo, Italy.ORCID 0000-0001-9576-1635
Adele FabianoNeonatal Intensive Care Unit, San Giovanni Hospital, 00184 Rome, Italy.ORCID 0000-0002-2886-2409
Caterina CacacePediatric Unit and NICU, "Barone Romeo" Hospital of ASP Messina, 98123 Messina, Italy.ORCID 0009-0009-8128-9670
Paola CavicchioliPediatric Unit, dell'Angelo Hospital Mestre, 30174 Venezia, Italy.
Armando CuttanoNeonatal Intensive Care Unit, University Hospital Pisa, 56100 Pisa, Italy.ORCID 0000-0003-4928-9354
Susanna Di ValerioNeonatal Intensive Care Unit, Santo Spirito Hospital, 65124 Pescara, Italy.
Cristiana GerminiNeonatal Unit, Perugia University Hospital, 06156 Perugia, Italy.
Marcello NapolitanoNeonatal Intensive Care and Neonatal Units, Evangelico Betania Hospital, 80100 Napoli, Italy.ORCID 0000-0003-0249-692X
Giulia PaviottiNeonatal Intensive Care Unit, University Hospital of Udine, 33100 Udine, Italy.
Chiara PeilaNeonal Unit, Department of Public Health and Pediatric Sciences, Turin University, 10126 Turin, Italy.ORCID 0000-0002-0075-5353
Serafina PerroneNeonatology Unit, Pietro Barilla Children's Hospital, University of Parma, 43125 Parma, Italy.ORCID 0000-0001-5478-5657
Simona PesceNeonatal Intensive Care Unit, San Carlo Hospital, 85100 Potenza, Italy.
Gianfranco ScarpelliNeonatal Intensive Care Unit and Pediatrics, Cosenza Hospital, 87100 Cosenza, Italy.
Grazia ScuttiNeonatal Intensive Care Unit, "Salesi" Hospital, 60126 Ancona, Italy.
Giuseppina SpaneddaNeonatal Intensive Care Unit, Sassari University Hospital, 07100 Sassari, Italy.
Alex StafflerNeonatal Intensive Care Unit, Division of Neonatology, Hospital of Bolzano, Teaching Hospital of Paracelsus Medical University, 39100 Bolzano, Italy.
Massimo AgostiNeonatal Intensive Care and Neonatal Units, Hospital of Varese-University of Insubria, 21100 Varese, Italy.ORCID 0000-0003-1828-821X
On Behalf Of The Italian Working Group On Rsv Prophylaxis Of Italian Society Of Neonatology

Funding

Italian Society of Neonatology will have in charge publication fees
6 · The paper itself

Abstract

Respiratory syncytial virus (RSV) remains a leading cause of lower respiratory tract infection (LRTI) and hospitalization in early infancy. Following the introduction of universal nirsevimab prophylaxis in Italy during the 2024-2025 RSV season, we evaluated its real-world effectiveness against RSV-associated hospitalization and severe clinical outcomes within a test-negative design framework. We conducted a multicenter retrospective test-negative study across 88 Italian neonatal centers, including infants hospitalized for LRTI from 1 September 2024 to 30 April 2025. Clinical data were collected from hospital records using a standardized electronic questionnaire. RSV-positive hospitalized infants were considered cases, and RSV-negative hospitalized infants served as controls. Secondary outcomes included respiratory support and Neonatal Intensive Care Unit (NICU) admission. Effectiveness was estimated using multivariable logistic regression and targeted maximum likelihood estimation. Overall, 737 infants were included, of whom 306 (41.52%) had previously received nirsevimab. RSV infection was identified in 398 infants (54.00%), including 104/306 (33.99%) nirsevimab-immunized and 294/431 (68.21%) non-immunized infants (

Indexed as

Antibodies, Monoclonal, HumanizedAntiviral AgentsBronchiolitisRespiratory Syncytial Virus InfectionsRespiratory Tract InfectionsFemaleHospitalizationHumansImmunization ProgramsInfantInfant, NewbornItalyMaleRespiratory Syncytial Virus, HumanRetrospective StudiesTreatment OutcomeAntibodies, Monoclonal, HumanizedAntiviral Agentsbronchiolitishospitalizationinfantlower respiratory tract infectionnewbornnirsevimabprophylaxisrespiratory supportRSV

Identifiers

PMID42797813
PMCPMC13611971

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.