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NEONATAL INFECTIONS: CASE DEFINITION AND GUIDELINES FOR DATA COLLECTION, ANALYSIS, AND PRESENTATION OF IMMUNISATION SAFETY DATA
Vergnano, Stefania et al. | Date Issued: 2016
Author
Vergnano, Stefania
Buttery, Jim
Cailes, Ben
Chandrasekaran, Ravichandran
Chiappini, Elena
Clark, Ebiere
Cutland, Clare
Andrade, Solange Dourado de
Esteves-Jaramillo, Alejandra
Guinazu, Javier Ruiz
Jones, Chrissie
Kampmann, Beate
King, Jay
Kochhar, Sonali
Macdonald, Noni
Mangili, Alexandra
Martins, Reinaldo de Menezes
Munoz, César Velasco
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.
The Brighton Collaboration Neonatal Infections Working Group
Affilliation
St. George’s University of London. Institute for Infection and Immunity. Pediatric Infectious Diseases Research Group. London, UK.
Monash Medical Centre. Clayton, Victoria, Australia.
St. George’s University of London. Institute for Infection and Immunity. Pediatric Infectious Diseases Research Group. London, UK.
Madras Medical College. India.
Florence University. Meyer Children’s Hospital. Italy.
Enhanced Vigilance Systems. UK.
University of the Witwatersrand. Wits Health Consortium. DST/NRF Respiratory and Meningeal Pathogens Research Unit. South Africa.
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado. Brasil.
Sanofi Pasteur. Global Pharmacovigilance. USA.
GSK Vaccines. Wavre, Belgium.
St. George’s University of London. Institute for Infection and Immunity. Pediatric Infectious Diseases Research Group. London, UK.
Imperial College. London, UK. / MRC Unit. The Gambia.
Sanofi Pasteur. Global Pharmacovigilance. USA.
Global Healthcare Consulting. India.
Dalhousie University. Departments of Paediatrics. Halifax, NS, Canada.
Novartis Vaccine. / GSK Vaccines. USA.
Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos. Rio de Janeiro, RJ, Brasil.
Universitad de Barcelona. ISGlobal. Barcelona Ctr. Int. Health Res. Barcelona, Spain.
The Children’s Hospital of Philadelphia and University of Pennsylvania. Division of Neonatology. USA.
Baylor College of Medicine. Houston, TX, USA.
New Jersey Medical School. Department of Pediatrics. Newark, NJ, USA.
Bill & Melinda Gates Foundation. Seattle, WA, USA.
Cincinnati Children’s Hospital Medical Center. Global Health Center. Division of Infectious Diseases. USA.
Henry Jackson Foundation. Bethesda, MD, USA.
National Institute of Public Health. Slovenia.
Emory University School of Medicine. Division of Pediatric Infectious Diseases. Centers for Disease Control and Prevention. USA.
University of Nigeria Teaching Hospital. Institute of Child Health. Nigeria.
Dalhousie University. Departments of Paediatrics. Halifax, NS, Canada.
University of Toronto. The Hospital for Sick Children. Department of Paediatrics. Division of Infectious Diseases. Canada.
St. George’s University of London. Institute for Infection and Immunity. Pediatric Infectious Diseases Research Group. London, UK.
Abstract in Portuguese
A vacinação materna é uma importante área de pesquisa e requer definições e padrões de segurança apropriados e internacionalmente comparáveis. O grupo GAIA, parte da Brighton Collaboration, foi criado com o mandato de propor definições padronizadas aplicáveis ​​à pesquisa de vacinas maternas. Este estudo propõe definições internacionais para infecções neonatais. O grupo de trabalho GAIA de infecções neonatais realizou uma revisão de literatura utilizando Medline, EMBASE e a colaboração Cochrane e coletou definições em uso em redes neonatais e de saúde pública. Os critérios comuns derivados da pesquisa extensiva formaram a base para um processo de consenso que resultou em três definições separadas para infecções da corrente sanguínea neonatal (BSI), meningite e infecções do trato respiratório inferior (ITRI). Para cada definição, três níveis de evidência são propostos para assegurar a aplicabilidade das definições a diferentes configurações. Recomendações sobre coleta, análise e apresentação de dados são apresentadas e harmonizadas com o formato Colaboração de Brighton e GAIA e outros padrões internacionais existentes para relatórios de estudo.
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.
Keywords in Portuguese
Infecções neonatais
Sepse
Meningite
Bacteriemia
Possível infecção bacteriana
Pneumonia
Bronquiolite
Perinatal
Recém-Nascido
Evento Adverso
Imunização
Diretrizes
Definição de caso
 
Keywords
Neonatal infections
Sepsis
Meningitis
Bacteremia
Possible bacterial infection
Pneumonia
Bronchiolitis
Perinatal
Newborn
Adverse event
Immunisation
Guidelines
Case definition
 
DeCS
Sepse
Meningite
Bacteriemia
Pneumonia
Bronquiolite
Recém-Nascido
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
 
Citation
VERGNANO, Stefania et al. Neonatal infections: case definition and guidelines for data collection, analysis, and presentation of immunisation safety data. Vaccine, v. 34, n. 1, p. 6038-6046, Dec. 2016.
DOI
10.1016/j.vaccine.2016.03.046
ISSN
0264-410X