Proposed Core Outcomes After Neonatal Sepsis: A Consensus Statement.

Summary

An international, multi-stakeholder process produced a 9-item Core Outcome Set for neonatal sepsis research, addressing heterogeneity in trial endpoints. The COS spans mortality, organ support, neurological injury, infection control, multi-organ dysfunction, neurodevelopment, and parental quality of life.

Key Findings

• Four-stage process (systematic review, real-time Delphi, consensus meetings, dissemination) across global stakeholders
• 306 participants identified 55 candidate outcomes; final COS includes 9 outcomes with ≥80% agreement
• COS items: all-cause mortality, need for mechanical ventilation, brain injury on imaging, neurologic status at discharge, antimicrobial escalation, CNS infections, multiorgan dysfunction, neurodevelopmental impairment, parental quality of life

Clinical Implications

Future neonatal sepsis trials should incorporate this 9-outcome COS to improve consistency, facilitate meta-analyses, and ensure patient- and family-centered endpoints.

Limitations

• Consensus methods do not establish measurement instruments or timing
• Potential selection bias in stakeholder participation and geographic representation

Future Directions

Develop standardized, validated instruments and timing for each COS item and promote adoption in registries and trial protocols.