Actively Recruiting

Age: 0Days - 7Days
All Genders
Healthy Volunteers
NCT07585149

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

Age: 0Days - 7Days
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Department of Paediatric and Child Health

Cork, Ireland, T12 DC4C

Actively Recruiting

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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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