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

Stefania Vergnano, Jim Buttery, Ben Cailes, Ravichandran Chandrasekaran, Elena Chiappini, Ebiere Clark, Clare Cutland, Solange Dourado de Andrade, Alejandra Esteves-Jaramillo, Javier Ruiz Guinazu, Chrissie Jones, Beate Kampmann, Jay King, Sonali Kochhar, Noni Macdonald, Alexandra Mangili, Reinaldo de Menezes Martins, César Velasco Muñoz, Michael Padula, Flor M. MuñozJames Oleske, Melvin Sanicas, Elizabeth Schlaudecker, Hans Spiegel, Maja Subelj, Lakshmi Sukumaran, Beckie N. Tagbo, Karina A. Top, Dat Tran, Paul T. Heath, The Brighton Collaboration Neonatal Infections Working Group

Research output: Contribution to journalArticleOtherpeer-review

15 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)6038-6046
Number of pages9
JournalVaccine
Volume34
Issue number49
DOIs
Publication statusPublished - 1 Dec 2016
Externally publishedYes

Keywords

  • Adverse event
  • Bacteremia
  • Bronchiolitis
  • Case definition
  • Guidelines
  • Immunisation
  • Meningitis
  • Neonatal infections
  • Newborn
  • Perinatal
  • Pneumonia
  • Possible bacterial infection
  • Sepsis

Cite this

Vergnano, S., Buttery, J., Cailes, B., Chandrasekaran, R., Chiappini, E., Clark, E., Cutland, C., de Andrade, S. D., Esteves-Jaramillo, A., Guinazu, J. R., Jones, C., Kampmann, B., King, J., Kochhar, S., Macdonald, N., Mangili, A., de Menezes Martins, R., Velasco Muñoz, C., Padula, M., ... The Brighton Collaboration Neonatal Infections Working Group (2016). Neonatal infections: Case definition and guidelines for data collection, analysis, and presentation of immunisation safety data. Vaccine, 34(49), 6038-6046. https://doi.org/10.1016/j.vaccine.2016.03.046