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Study identifier: NCT07585149 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Generating Intervals of Reference FFor Early Life Brain Biomarkers.

Condition: Reference Intervals · Biomarker in Early Diagnosis · Neonatal  ·  Sponsor: University College Cork

PhaseN/A
Planned participants150
Who can joinAll sexes, 0 Days to 7 Days
Healthy volunteersYes

About this study

Highly sensitive immunoassays for the detection of neuro-specific biomarkers are becoming more accessible. Currently, the majority of these biomarkers are detected with the use of labour-intensive and highly skilled wet lab work. However, recent advancements have allowed for the introduction of these neuro-specific biomarkers into mainstream clinical chemistry analysers, bringing them closer to clinical care. There is a vast amount of published literature for neuro-specific biomarkers in an adult and ageing population, unfortunately, the same cannot be said for the neonatal population. From the limited available literature, clear differences are being documented in physiological levels of neuro-specific biomarkers in adults and infants. Neuro-specific biomarkers such as GFAP (Glial Fibrillary Acidic Protein) and Tau are demonstrating promise for the early detection and prediction of neuro-developmental disorders. There is a need for an understanding of physiological levels of these neuro-specific biomarkers in a neonatal population before they can be fully adopted into clinical routine. The development of a neonatal reference interval for neuro-specific biomarkers may provide a foundation for the accurate interpretation of neuro-specific biomarker elevations in neonatal brain injury, aiding in the development of biomarker-based screening tools for early diagnosis and intervention.

This description comes directly from the study's public registry record.

Talk to the study team

Conor L Vaughan, BSc, MSc  ·  +353876068018  ·  conor.vaughan@ucc.ie

Deirdre M Murray, PhD  ·  d.murray@ucc.ie

Always discuss trial participation with your own doctor first.

Locations (1)

Department of Paediatric and Child HealthCork, IrelandRecruiting

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Source record: clinicaltrials.gov/study/NCT07585149