NNRD for NeoSep-ADAPT
Research type
Research Study
Full title
Assessing feasibility of determining eligibility and clinical outcome measures for neonatal sepsis trials in the UK from routinely collected data: National Neonatal Research Database (NNRD) analysis for NeoSep-ADAPT
IRAS ID
355848
Contact name
Julia Bielicki
Contact email
Sponsor organisation
City St. George's University London
Duration of Study in the UK
1 years, 0 months, 30 days
Research summary
This study focuses on infants admitted to neonatal units with sepsis. The goal of this study is to investigate the performance of different neonatal sepsis definitions in detecting cases of infants with neonatal sepsis. A database which holds data on all admissions to NHS neonatal units in the United Kingdom (excluding Northern Ireland) will be used to investigate the research objectives. The database is named the National Neonatal Research Database (NNRD). The research will investigate and compare ‘internal’ definitions (used within the NNRD) and ‘external’ definitions (used in clinical research studies). An additional aim of the study is to validate a clinical score, named the ‘NeoSep Severity Score’. The score was developed to assess the probability of death when an infant has sepsis. Validation means a score has been evaluated to confirm it accurately reflects its intended measurement.
Infections are an important problem in UK neonatal intensive care units (NICUs). They are common and can be difficult to diagnose and treat. The definitions for sepsis which are currently available lack applicability to infants and neonates, and also to different resource settings. A validated universal definition for neonatal sepsis would benefit clinical care, and can be used by researchers as a tool to conduct more suitable research for this population.
This study aims to apply different definitions to the database to assess how they perform in identifying infants with neonatal sepsis from routine data, for general case detection, and for research involvement.REC name
West Midlands - Black Country Research Ethics Committee
REC reference
26/WM/0058
Date of REC Opinion
24 Mar 2026
REC opinion
Favourable Opinion