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

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 vaccin...

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Bibliographic Details
Published in:	Vaccine Vol. 34; no. 49; pp. 6038 - 6046
Main Authors:	Vergnano, Stefania, Buttery, Jim, Cailes, Ben, Chandrasekaran, Ravichandran, Chiappini, Elena, Clark, Ebiere, Cutland, Clare, de Andrade, Solange Dourado, Esteves-Jaramillo, Alejandra, Guinazu, Javier Ruiz, Jones, Chrissie, Kampmann, Beate, King, Jay, Kochhar, Sonali, Macdonald, Noni, Mangili, Alexandra, de Menezes Martins, Reinaldo, Velasco Muñoz, César, Padula, Michael, Muñoz, Flor M, Oleske, James, Sanicas, Melvin, Schlaudecker, Elizabeth, Spiegel, Hans, Subelj, Maja, Sukumaran, Lakshmi, Tagbo, Beckie N, Top, Karina A, Tran, Dat, Heath, Paul T
Format:	Journal Article
Language:	English
Published:	Netherlands Elsevier Ltd 01-12-2016 Elsevier Limited Elsevier Elsevier Science
Subjects:	Adverse event Allergy and Immunology Babies Bacteremia Bacteremia - epidemiology Bacteremia - prevention & control Bacterial infections Bronchiolitis Case definition Clinical trials Coma Communicable Disease Control Data Collection Decision making Female Guidelines Hospitals Humans Immunisation Immunization Immunization - adverse effects Infant, Newborn Infants nadons Infections Infections - epidemiology International standards Laboratories Library collections Literature reviews Malalties neonatals Meningitis Meningitis - epidemiology Meningitis - prevention & control Mortality Neonatal diseases Neonatal infections Newborn Newborn infants Pathogens Perinatal Pneumonia Possible bacterial infection Public health Respiratory tract Sepsis Sepsis - epidemiology Sepsis - prevention & control Statistics as Topic Studies Vaccines Vaccines - adverse effects Viral infections Working groups Pneumonia Case definition Immunisation Perinatal Adverse event Possible bacterial infection Bacteremia Bronchiolitis Guidelines Newborn Neonatal infections Sepsis Meningitis
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Summary:	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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 Brighton Collaboration homepage: http://www.brightoncollaboration.org.
ISSN:	0264-410X 1873-2518
DOI:	10.1016/j.vaccine.2016.03.046