Establishing Normal Levels of Brain Biomarkers in Term Neonates During Their First Week of Life

What this Trial Is About

Researchers are studying neuro-specific biomarkers to better understand their normal levels in newborn babies. These biomarkers, such as GFAP and Tau proteins, show promise in detecting brain injuries and predicting developmental problems early in life. While these markers are well studied in adults, little is known about their typical levels in newborns, which is important to help interpret abnormal findings and improve diagnosis and care in neonatal brain injury. The study will observe healthy full-term newborns born at 37 weeks or later within their first week of life. Blood samples will be taken during routine venipuncture to measure biomarkers GFAP, Tau, and specific microRNAs linked to brain development and injury. The research aims to establish reference ranges for these biomarkers in newborns using advanced clinical chemistry analyzers, making these tests more accessible in clinical settings. Participants will provide blood samples and relevant clinical information like gestational age, birth weight, and delivery details. Researchers will analyze these samples to define normal biomarker levels in newborns. The main outcome is the development of reference intervals for these neuro-specific biomarkers from birth to one week old. This will help guide future use of these markers in diagnosing neonatal brain injury and predicting outcomes. The study runs until June 2027.

Generating Intervals of Reference FFor Early Life Brain Biomarkers.