RecruitingNCT07585149

Generating Intervals of Reference FFor Early Life Brain Biomarkers.


Sponsor

University College Cork

Enrollment

150 participants

Start Date

Apr 13, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 0 DaysMax Age: 7 Days

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a new treatment for people with biomarker in early diagnosis, neonatal, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 0 Days to 7 Days.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(1)

Department of Paediatric and Child Health

Cork, Ireland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07585149


Related Trials