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

File Description SizeFormat 
1-s2.0-S0264410X16300299-main.pdfPublished version550.76 kBAdobe PDFDownload
Title: Neonatal infections: case definition and guidelines for data collection, analysis, and presentation of immunisation safety data.
Author(s): Vergnano, S
Buttery, J
Cailes, B
Chandrasekaran, R
Chiappini, E
Clark, E
Cutland, C
De Andrade, SD
Esteves-Jaramillo, A
Guinazu, JR
Jones, C
Kampmann, B
King, J
Kochhar, S
Macdonald, N
Mangili, A
De Menezes Martins, R
Muñoz, CV
Padula, M
Muñoz, FM
Oleske, J
Sanicas, M
Schlaudecker, E
Spiegel, H
Subelj, M
Sukumaran, L
Tagbo, BN
Top, KA
Tran, D
Heath, PT
Brighton Collaboration Neonatal Infections Working Group
Item Type: Journal 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.
Publication Date: 1-Aug-2016
Date of Acceptance: 1-Aug-2016
URI: http://hdl.handle.net/10044/1/39429
DOI: https://dx.doi.org/10.1016/j.vaccine.2016.03.046
ISSN: 0264-410X
Publisher: Elsevier
Start Page: 6038
End Page: 6046
Journal / Book Title: Vaccine
Volume: 34
Issue: 49
Copyright Statement: © 2016 Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Copyright Statement: © 2016 Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Keywords: Adverse event
Bacteremia
Bronchiolitis
Case definition
Guidelines
Immunisation
Meningitis
Neonatal infections
Newborn
Perinatal
Pneumonia
Possible bacterial infection
Sepsis
Brighton Collaboration Neonatal Infections Working Group
Virology
06 Biological Sciences
07 Agricultural And Veterinary Sciences
11 Medical And Health Sciences
Publication Status: Published
Appears in Collections:Department of Medicine
Faculty of Medicine



Items in Spiral are protected by copyright, with all rights reserved, unless otherwise indicated.

Creative Commons