title: 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 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.
authors: Paediatric Infectious Diseases Research Group, Institute for Infection and Immunity, St George's University of London, UK.
authors: Stefania
authors: S
authors: Vergnano
authors: Monash Medical Centre, Clayton, Victoria 3168, Australia.
authors: Jim
authors: J
authors: Buttery
authors: Paediatric Infectious Diseases Research Group, Institute for Infection and Immunity, St George's University of London, UK.
authors: Ben
authors: B
authors: Cailes
authors: Madras Medical College, India.
authors: Ravichandran
authors: R
authors: Chandrasekaran
authors: Meyer Children's Hospital, Florence University, Italy.
authors: Elena
authors: E
authors: Chiappini
authors: Enhanced Vigilance Systems, UK.
authors: Ebiere
authors: E
authors: Clark
authors: University of the Witwatersrand, Wits Health Consortium, DST/NRF Respiratory and Meningeal Pathogens Research Unit (RMPRU), South Africa.
authors: Clare
authors: C
authors: Cutland
authors: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Brazil.
authors: Solange Dourado
authors: SD
authors: de Andrade
authors: Global Pharmacovigilance, Sanofi Pasteur, USA.
authors: Alejandra
authors: A
authors: Esteves-Jaramillo
authors: GSK Vaccines, Wavre, Belgium.
authors: Javier Ruiz
authors: JR
authors: Guinazu
authors: Paediatric Infectious Diseases Research Group, Institute for Infection and Immunity, St George's University of London, UK.
authors: Chrissie
authors: C
authors: Jones
authors: Imperial College, London, UK; MRC Unit, The Gambia.
authors: Beate
authors: B
authors: Kampmann
authors: Global Pharmacovigilance, Sanofi Pasteur, USA.
authors: Jay
authors: J
authors: King
authors: Global Healthcare Consulting, India.
authors: Sonali
authors: S
authors: Kochhar
authors: Departments of Paediatrics, Dalhousie University, Halifax, NS, Canada.
authors: Noni
authors: N
authors: Macdonald
authors: Novartis Vaccine/GSK Vaccines, USA.
authors: Alexandra
authors: A
authors: Mangili
authors: Bio Manguinhos/Fiocruz, Brazil.
authors: Reinaldo
authors: R
authors: de Menezes Martins
authors: ISGlobal, Barcelona Ctr. Int. Health Res. (CRESIB), Universitad de Barcelona, Spain.
authors: César
authors: C
authors: Velasco Muñoz
authors: Division of Neonatology, The Children's Hospital of Philadelphia and University of Pennsylvania, USA.
authors: Michael
authors: M
authors: Padula
authors: Baylor College of Medicine, Houston, TX, USA.
authors: Flor M
authors: FM
authors: Muñoz
authors: Department of Pediatrics, Rutgers - New Jersey Medical School, Newark, NJ, USA.
authors: James
authors: J
authors: Oleske
authors: Bill & Melinda Gates Foundation, Seattle, WA, USA.
authors: Melvin
authors: M
authors: Sanicas
authors: Division of Infectious Diseases, Global Health Center, Cincinnati Children's Hospital Medical Center, USA.
authors: Elizabeth
authors: E
authors: Schlaudecker
authors: Henry Jackson Foundation, Bethesda, MD, USA.
authors: Hans
authors: H
authors: Spiegel
authors: National Institute of Public Health (NIJZ), Slovenia.
authors: Maja
authors: M
authors: Subelj
authors: Centers for Disease Control and Prevention, Division of Pediatric Infectious Diseases - Emory University School of Medicine, USA.
authors: Lakshmi
authors: L
authors: Sukumaran
authors: Institute of Child Health, University of Nigeria Teaching Hospital, Nigeria.
authors: Beckie N
authors: BN
authors: Tagbo
authors: Departments of Paediatrics, Dalhousie University, Halifax, NS, Canada.
authors: Karina A
authors: KA
authors: Top
authors: Division of Infectious Diseases, Department of Paediatrics, The Hospital for Sick Children, University of Toronto, Canada.
authors: Dat
authors: D
authors: Tran
authors: Paediatric Infectious Diseases Research Group, Institute for Infection and Immunity, St George's University of London, UK. Electronic address: contact@brightoncollaboration.org.
authors: Paul T
authors: PT
authors: Heath
mesh_terms: D016470:Bacteremia / Q000453:epidemiology / Q000517:prevention & control; D003140:Communicable Disease Control; D003625:Data Collection; D005260:Female; D006801:Humans; D007114:Immunization / Q000009:adverse effects*; D007231:Infant, Newborn; D007239:Infections / Q000453:epidemiology*; D008581:Meningitis / Q000453:epidemiology / Q000517:prevention & control; D018805:Sepsis / Q000453:epidemiology / Q000517:prevention & control; D013223:Statistics as Topic; D014612:Vaccines / Q000009:adverse effects*
chemical_list: D014612:Vaccines
keywords: Adverse event; Bacteremia; Bronchiolitis; Case definition; Guidelines; Immunisation; Meningitis; Neonatal infections; Newborn; Perinatal; Pneumonia; Possible bacterial infection; Sepsis