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Neonatal infections: case definition and guidelines for data collection, analysis, and presentation of immunisation safety data

Neonatal infections: case definition and guidelines for data collection, analysis, and presentation of immunisation safety data
Neonatal infections: case definition and guidelines for data collection, analysis, and presentation of immunisation safety data
Maternal vaccination is an important area of research and requires appropriate and internationally comparable definitions and safety standards. The GAIA group, part of the Brighton Collaboration was created with the mandate of proposing standardised definitions applicable to maternal vaccine research. This study proposes international definitions for neonatal infections. The neonatal infections GAIA working group performed a literature review using Medline, EMBASE and the Cochrane collaboration and collected definitions in use in neonatal and public health networks. The common criteria derived from the extensive search formed the basis for a consensus process that resulted in three separate definitions for neonatal blood stream infections (BSI), meningitis and lower respiratory tract infections (LRTI). For each definition three levels of evidence are proposed to ensure the applicability of the definitions to different settings. Recommendations about data collection, analysis and presentation are presented and harmonized with the Brighton Collaboration and GAIA format and other existing international standards for study reporting.
Adverse event, Bacteremia, Bronchiolitis, Case definition, Guidelines, Immunisation, Meningitis, Neonatal infections, Newborn, Perinatal, Pneumonia, Possible bacterial infection, Sepsis
0264-410X
6038-6046
Vergnano, Stefania
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Buttery, Jim
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Cailes, Ben
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Chandrasekaran, Ravichandran
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Chiappini, Elena
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Clark, Ebiere
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Cutland, Clare
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de Andrade, Solange Dourado
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Esteves-Jaramillo, Alejandra
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Guinazu, Javier Ruiz
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Jones, Chrissie
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Kampmann, Beate
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King, Jay
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Kochhar, Sonali
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Macdonald, Noni
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Mangili, Alexandra
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de Menezes Martins, Reinaldo
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Velasco Muñoz, César
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Padula, Michael
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Muñoz, Flor M.
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Oleske, James
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Sanicas, Melvin
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Schlaudecker, Elizabeth
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Spiegel, Hans
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Subelj, Maja
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Sukumaran, Lakshmi
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Tagbo, Beckie N.
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Top, Karina A.
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Tran, Dat
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Heath, Paul T.
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The Brighton Collaboration Neonatal Infections Working Group
Vergnano, Stefania
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Buttery, Jim
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Cailes, Ben
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Chandrasekaran, Ravichandran
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Chiappini, Elena
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Clark, Ebiere
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Cutland, Clare
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de Andrade, Solange Dourado
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Esteves-Jaramillo, Alejandra
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Guinazu, Javier Ruiz
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Jones, Chrissie
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Kampmann, Beate
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King, Jay
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Kochhar, Sonali
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Macdonald, Noni
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Mangili, Alexandra
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de Menezes Martins, Reinaldo
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Velasco Muñoz, César
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Padula, Michael
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Muñoz, Flor M.
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Oleske, James
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Sanicas, Melvin
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Schlaudecker, Elizabeth
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Spiegel, Hans
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Subelj, Maja
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Sukumaran, Lakshmi
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Tagbo, Beckie N.
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Top, Karina A.
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Tran, Dat
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Heath, Paul T.
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Vergnano, Stefania, Buttery, Jim, Cailes, Ben, Jones, Chrissie and Heath, Paul T. , The Brighton Collaboration Neonatal Infections Working Group (2016) Neonatal infections: case definition and guidelines for data collection, analysis, and presentation of immunisation safety data. Vaccine, 34 (49), 6038-6046. (doi:10.1016/j.vaccine.2016.03.046).

Record type: Article

Abstract

Maternal vaccination is an important area of research and requires appropriate and internationally comparable definitions and safety standards. The GAIA group, part of the Brighton Collaboration was created with the mandate of proposing standardised definitions applicable to maternal vaccine research. This study proposes international definitions for neonatal infections. The neonatal infections GAIA working group performed a literature review using Medline, EMBASE and the Cochrane collaboration and collected definitions in use in neonatal and public health networks. The common criteria derived from the extensive search formed the basis for a consensus process that resulted in three separate definitions for neonatal blood stream infections (BSI), meningitis and lower respiratory tract infections (LRTI). For each definition three levels of evidence are proposed to ensure the applicability of the definitions to different settings. Recommendations about data collection, analysis and presentation are presented and harmonized with the Brighton Collaboration and GAIA format and other existing international standards for study reporting.

This record has no associated files available for download.

More information

Published date: 1 December 2016
Additional Information: Funding Information: The authors are grateful for the support and helpful comments provided by the Brighton Collaboration (Jan Bonhoeffer, Jorgen Bauwens) and the reference group (see https://brightoncollaboration.org/public/what-we-do/setting-standards/case-definitions/groups.html for reviewers), as well as other experts consulted as part of the process. The authors are also grateful to the Brighton Collaboration Secretariat and to the members of the ISPE Special Interest Group in Vaccines (VAX SIG) for their review and constructive comments on this document. Finally, we would like to acknowledge the Global Alignment of Immunisation Safety Assessment in Pregnancy (GAIA) project, funded by the Bill and Melinda Gates Foundation . Publisher Copyright: © 2016
Keywords: Adverse event, Bacteremia, Bronchiolitis, Case definition, Guidelines, Immunisation, Meningitis, Neonatal infections, Newborn, Perinatal, Pneumonia, Possible bacterial infection, Sepsis

Identifiers

Local EPrints ID: 474863
URI: http://eprints.soton.ac.uk/id/eprint/474863
ISSN: 0264-410X
PURE UUID: 94de6559-fa13-4c60-a5ad-fb016193f9bf
ORCID for Chrissie Jones: ORCID iD orcid.org/0000-0003-1523-2368

Catalogue record

Date deposited: 03 Mar 2023 17:51
Last modified: 18 Mar 2024 03:39

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Contributors

Author: Stefania Vergnano
Author: Jim Buttery
Author: Ben Cailes
Author: Ravichandran Chandrasekaran
Author: Elena Chiappini
Author: Ebiere Clark
Author: Clare Cutland
Author: Solange Dourado de Andrade
Author: Alejandra Esteves-Jaramillo
Author: Javier Ruiz Guinazu
Author: Chrissie Jones ORCID iD
Author: Beate Kampmann
Author: Jay King
Author: Sonali Kochhar
Author: Noni Macdonald
Author: Alexandra Mangili
Author: Reinaldo de Menezes Martins
Author: César Velasco Muñoz
Author: Michael Padula
Author: Flor M. Muñoz
Author: James Oleske
Author: Melvin Sanicas
Author: Elizabeth Schlaudecker
Author: Hans Spiegel
Author: Maja Subelj
Author: Lakshmi Sukumaran
Author: Beckie N. Tagbo
Author: Karina A. Top
Author: Dat Tran
Author: Paul T. Heath
Corporate Author: The Brighton Collaboration Neonatal Infections Working Group

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