Generating Intervals of Reference FFor Early Life Brain Biomarkers.
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 bio
| Condition(s) | Reference Intervals, Biomarker in Early Diagnosis, Neonatal |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 Fibrill |
| Who can participate | 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. |
| Ages | 0 Days to 7 Days |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | University College Cork |
| Locations | Cork, Ireland |
| Start date | 2026-04-13 |
| NCT ID | NCT07585149 |
| Official listing | https://clinicaltrials.gov/study/NCT07585149 |