The neonatal adverse event severity scale: current status, a stakeholders' assessment, and future perspectives

Area of Science:

• Neonatal clinical trials
• Drug safety and efficacy assessment
• Medical device development

Background:

• Standardized tools are crucial for reproducible clinical trial results and comparative analysis of therapeutic interventions.
• Assessing seriousness, causality, and severity of adverse events is vital for drug safety evaluation.
• The international Neonatal Consortium (INC) developed the neonatal adverse event severity scale (NAESS) as part of a comprehensive assessment toolbox.

Purpose of the Study:

• To report on the development, validation, and impact of the neonatal adverse event severity scale (NAESS).
• To evaluate stakeholder perspectives on the relevance and future development of the NAESS tool.
• To highlight the role of NAESS in supporting drug registration and prescription decisions.

Main Methods:

• Development of the initial NAESS version by the INC.
• Validation of NAESS in retrospective and prospective clinical trials.
• Analysis of NAESS usage in regulatory documents, trial protocols, and study reports by regulators, sponsors, and researchers.

Main Results:

• The NAESS scale has undergone validation, demonstrating its applicability and impact on inter-observer variability in neonatal trials.
• Stakeholders have reported on the use of NAESS in various clinical trial documentation.
• The tool has been utilized by regulators, sponsors, and academic researchers.

Conclusions:

• The NAESS tool has shown utility in standardizing the assessment of adverse events in neonatal populations.
• Further development of the NAESS is considered to enhance its utility in clinical practice and research.
• The NAESS contributes to informed decision-making regarding drug safety and efficacy in neonates.