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

Area of Science:

• Neonatal infectious diseases
• Vaccinology
• Global public health

Background:

• Maternal vaccination research necessitates standardized definitions and safety protocols for international comparability.
• The GAIA (Good practices for Assessing Immunization safety in pregnancy) group, under the Brighton Collaboration, was established to create these standardized definitions.
• Existing definitions for neonatal infections varied across public health networks, hindering consistent research.

Framework:

• A comprehensive literature review of Medline, EMBASE, and the Cochrane collaboration identified current definitions for neonatal infections.
• A consensus process involving the GAIA working group refined common criteria from the literature review.
• Three distinct, internationally applicable definitions were proposed for neonatal blood stream infections (BSI), meningitis, and lower respiratory tract infections (LRTI).

Implementation:

• Each definition includes three proposed levels of evidence to accommodate diverse research settings.
• Recommendations for data collection, analysis, and presentation are provided.
• These recommendations align with the Brighton Collaboration and GAIA formats and existing international reporting standards.

Implications:

• The proposed definitions will standardize the reporting of neonatal infections in maternal vaccine studies.
• Harmonized definitions will improve the quality and comparability of safety data in maternal immunization research.
• This initiative supports the development of evidence-based recommendations for maternal vaccination globally.