NCT07585149 Generating Intervals of Reference FFor Early Life Brain Biomarkers.
| NCT ID | NCT07585149 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University College Cork |
| Condition | Reference Intervals |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-04-13 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2026-04-13 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * When the relevant demographic/clinical information is not available.
Contact & Investigator
Deirdre M Murray, PhD
PRINCIPAL INVESTIGATOR
INFANT Research Centre, University College Cork
Frequently Asked Questions
Who can join the NCT07585149 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 7 Days, studying Reference Intervals. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07585149 currently recruiting?
Yes, NCT07585149 is actively recruiting participants. Contact the research team at conor.vaughan@ucc.ie for enrollment information.
Where is the NCT07585149 trial being conducted?
This trial is being conducted at Cork, Ireland.
Who is sponsoring the NCT07585149 clinical trial?
NCT07585149 is sponsored by University College Cork. The principal investigator is Deirdre M Murray, PhD at INFANT Research Centre, University College Cork. The trial plans to enroll 150 participants.
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