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

Autor: Vergnano S; Paediatric Infectious Diseases Research Group, Institute for Infection and Immunity, St George's University of London, UK., Buttery J; Monash Medical Centre, Clayton, Victoria 3168, Australia., Cailes B; Paediatric Infectious Diseases Research Group, Institute for Infection and Immunity, St George's University of London, UK., Chandrasekaran R; Madras Medical College, India., Chiappini E; Meyer Children's Hospital, Florence University, Italy., Clark E; Enhanced Vigilance Systems, UK., Cutland C; University of the Witwatersrand, Wits Health Consortium, DST/NRF Respiratory and Meningeal Pathogens Research Unit (RMPRU), South Africa., de Andrade SD; Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Brazil., Esteves-Jaramillo A; Global Pharmacovigilance, Sanofi Pasteur, USA., Guinazu JR; GSK Vaccines, Wavre, Belgium., Jones C; Paediatric Infectious Diseases Research Group, Institute for Infection and Immunity, St George's University of London, UK., Kampmann B; Imperial College, London, UK; MRC Unit, The Gambia., King J; Global Pharmacovigilance, Sanofi Pasteur, USA., Kochhar S; Global Healthcare Consulting, India., Macdonald N; Departments of Paediatrics, Dalhousie University, Halifax, NS, Canada., Mangili A; Novartis Vaccine/GSK Vaccines, USA., de Menezes Martins R; Bio Manguinhos/Fiocruz, Brazil., Velasco Muñoz C; ISGlobal, Barcelona Ctr. Int. Health Res. (CRESIB), Universitad de Barcelona, Spain., Padula M; Division of Neonatology, The Children's Hospital of Philadelphia and University of Pennsylvania, USA., Muñoz FM; Baylor College of Medicine, Houston, TX, USA., Oleske J; Department of Pediatrics, Rutgers - New Jersey Medical School, Newark, NJ, USA., Sanicas M; Bill & Melinda Gates Foundation, Seattle, WA, USA., Schlaudecker E; Division of Infectious Diseases, Global Health Center, Cincinnati Children's Hospital Medical Center, USA., Spiegel H; Henry Jackson Foundation, Bethesda, MD, USA., Subelj M; National Institute of Public Health (NIJZ), Slovenia., Sukumaran L; Centers for Disease Control and Prevention, Division of Pediatric Infectious Diseases - Emory University School of Medicine, USA., Tagbo BN; Institute of Child Health, University of Nigeria Teaching Hospital, Nigeria., Top KA; Departments of Paediatrics, Dalhousie University, Halifax, NS, Canada., Tran D; Division of Infectious Diseases, Department of Paediatrics, The Hospital for Sick Children, University of Toronto, Canada., Heath PT; Paediatric Infectious Diseases Research Group, Institute for Infection and Immunity, St George's University of London, UK. Electronic address: contact@brightoncollaboration.org.
Jazyk: angličtina
Zdroj: Vaccine [Vaccine] 2016 Dec 01; Vol. 34 (49), pp. 6038-6046. Date of Electronic Publication: 2016 Aug 01.
DOI: 10.1016/j.vaccine.2016.03.046
Abstrakt: 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.
(Copyright © 2016. Published by Elsevier Ltd.)
Databáze: MEDLINE