Reference intervals for newborn brain biomarkers
Official title: Generating Intervals of Reference FFor Early Life Brain Biomarkers.
Run by University College Cork · NCT07585149 · Data updated 2026-11-12
Measure levels of brain-specific blood proteins (such as GFAP and Tau) in healthy full-term newborns during their first week of life to create normal reference ranges.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Days to 7 Days |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | University College Cork Academic / other |
| Locations | 1 site (Cork) |
| Status | Recruiting |
| Started | April 13, 2026 |
| Main results expected | March 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | May 13, 2026 |
| Trial ID | NCT07585149 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Full-term (≥37 weeks) newborns whose parents consent and who have a planned routine venous blood draw within one week of life with no clinical evidence of neurological problems or major illness.
✕Probably not a fit
Preterm infants, babies admitted to the NICU, or those with suspected infection, known metabolic, chromosomal, or congenital abnormalities are excluded and therefore will not directly benefit from these reference ranges.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project collects a routine venous blood sample from full-term newborns within the first week of life and measures neuro-specific biomarkers such as GFAP and Tau using clinically compatible high-sensitivity immunoassays. Infants with prematurity, NICU admission, suspected infection, inborn errors of metabolism, chromosomal or congenital abnormalities are excluded to define physiological rather than pathological levels. Relevant demographic and clinical data (gestational age, birth weight, mode of delivery, sex, race, and 5-minute Apgar) will be recorded to enable stratified reference intervals. The aim is to produce robust neonatal reference intervals that can be implemented on mainstream clinical chemistry analyzers to support earlier detection and prediction of neurodevelopmental risk.
Why it matters
Potential benefit: If successful, clinicians would gain validated normal ranges for neonatal GFAP, Tau and similar markers that could improve early detection and prognostication of brain injury or neurodevelopmental risk.
How similar studies have gone: Comparable biomarker reference work has been successful in adults and older children, and early reports suggest GFAP and Tau are promising in neonates, but neonatal reference data remain limited.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Department of Paediatric and Child Health
Cork, Ireland Recruiting
Study contacts
- Principal investigator: Deirdre M Murray, PhD — INFANT Research Centre, University College Cork
- Study coordinator: Conor L Vaughan, BSc, MSc
- Email: conor.vaughan@ucc.ie
- Phone: +353876068018
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.