Actively Recruiting
Generating Intervals of Reference FFor Early Life Brain Biomarkers.
Led by University College Cork · Updated on 2026-05-13
150
Participants Needed
1
Research Sites
63 weeks
Total Duration
On this page
Sponsors
U
University College Cork
Lead Sponsor
I
INFANT centre, University College Cork, Republic of Ireland
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Generating Intervals of Reference FFor Early Life Brain Biomarkers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Term neonate (≥37 weeks)
- Planned routine venous blood drawn within one week of life
- Relevant demographic and clinical information available, including gestational age, day of life, birth weight, sex, race, mode of delivery, and 5-minute Apgar score
- Informed parental consent obtained prior to any study procedures
You will not qualify if you...
- Pre-term neonates <37 weeks
- Any clinical evidence of neurological or central nervous system abnormalities
- Admission to neonatal intensive care unit (NICU)
- Suspected or culture-positive sepsis or meningitis
- Known inborn errors of metabolism
- Known chromosomal abnormalities or apparent congenital abnormalities
- Lack of relevant demographic or clinical information
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Paediatric and Child Health
Cork, Ireland, T12 DC4C
Actively Recruiting
Research Team
C
Conor L Vaughan, BSc, MSc
CONTACT
D
Deirdre M Murray, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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