Development of a neonatal adverse event severity scale through a Delphi consensus approach

Area of Science:

• Neonatalogy
• Clinical Pharmacology
• Biostatistics

Background:

• Standardized assessment of adverse events (AEs) is crucial for clinical trial safety and comparability.
• Existing AE severity scales are not suitable for neonates, highlighting a need for a specialized tool.
• Accurate AE severity assessment is vital for understanding AE importance in clinical settings.

Purpose of the Study:

• To develop and validate a standardized scale for assessing adverse event severity in neonatal clinical trials.
• To establish reliable and comparable safety information across neonatal studies.

Main Methods:

• A stepwise consensus process involving stakeholders within the International Neonatal Consortium (INC).
• Utilized a Delphi approach with multiple survey rounds, face-to-face meetings, and pilot validation.
• Developed criteria based on the AE's effect on age-appropriate behavior, physiological functions, and care modifications.

Main Results:

• The International Neonatal Consortium (INC) Neonatal Adverse Event Severity Scale (NAESS) V.1.0 was developed.
• The scale classifies neonatal AE severity into five grades: mild, moderate, severe, life-threatening, or death.
• Pilot validation demonstrated the scale's utility, leading to refinement and public availability.

Conclusions:

• The INC NAESS provides a standardized method for grading AE severity in neonates.
• This scale enhances the reliability and comparability of safety data in neonatal clinical trials.
• Future work includes ongoing updates, further validation, and user training module development.