Reference intervals for newborn brain biomarkers
Generating Intervals of Reference FFor Early Life Brain Biomarkers.
University College Cork · NCT07585149
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 |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 0 Days to 7 Days |
| Sex | All |
| Sponsor | University College Cork (other) |
| Locations | 1 site (Cork) |
| Trial ID | NCT07585149 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cork
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Reference Intervals, Biomarker in Early Diagnosis, Neonatal, Neurospecific, Biomarker, Reference Interval