Generating Intervals of Reference FFor Early Life Brain Biomarkers.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-7
SponsorUniversity College Cork

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Term neonate (≥37 weeks)

Planned routine venous blood drawn within one week of life

Relevant demographic/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

Disqualifiers

Pre-term neonates <37 weeks

Any clinical evidence of neurological/ CNS abnormalities.

NICU admission

Any neonates with Suspected or culture-positive sepsis or meningitis Any known inborn errors of metabolism (IEM). Any known chromosomal abnormalities or any apparent congenital abnormalities

Trial population

Healthy term neonates who are due to have routine clinical bloods within their first week of life will be recruited for this study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 1 trial group
Group A: Term Neonate

Trial outcomes

Primary outcomes

1

Neurospecific Reference Interval

To examine the underlying normative neuro-specific protein profiles of term neonates.

Time frame
Birth to 1 week

Secondary outcomes

Other outcomes

Sponsors and contacts

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University College Cork

Lead sponsor

INFANT centre, University College Cork, Republic of Ireland

Collaborator