Validation of Altered Umbilical Cord Blood MicroRNA Expression in Neonatal Hypoxic-Ischemic Encephalopathy.
Marc Paul O'Sullivan, Ann Marie Looney, Gerard M Moloney...
https://pubmed.ncbi.nlm.nih.gov/30592487Actively Recruiting
Age: 0Days - 7Days
All Genders
Healthy Volunteers
ID07585149
Generating Reference Intervals for Early Life Brain Biomarkers in Newborns
Led by University College Cork · Updated on 2026-05-13
150
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
U
University College Cork
Lead Sponsor
I
INFANT centre, University College Cork, Republic of Ireland
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Generating Intervals of Reference FFor Early Life Brain Biomarkers.
Who Can Participate
Age: 0Days - 7Days
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Term neonate (≥37 weeks gestational age)
- Planned routine venous blood draw within one week of life
- Available relevant demographic and clinical information including gestational age, day of life, birth weight, sex, race, mode of delivery, and 5-minute Apgar score
- Informed parental consent obtained before any study procedures
You will not qualify if you...
- Pre-term neonates under 37 weeks gestational age
- Any clinical signs of neurological or central nervous system abnormalities
- Admission to neonatal intensive care unit (NICU)
- Suspected or confirmed sepsis or meningitis
- Known inborn errors of metabolism
- Known chromosomal or apparent congenital abnormalities
- Missing relevant demographic or clinical information
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Up to 1 week
Participants have blood samples collected within their first week of life to measure neuro-specific biomarkers and gather relevant demographic and clinical information.
1 visit (in-person) within the first week of life
Trial Site Locations
Total: 1 location
1
Department of Paediatric and Child Health
Cork, Ireland, T12 DC4C
Actively Recruiting
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Research Team
C
Conor L Vaughan, BSc, MSc
D
Deirdre M Murray, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
MicroRNAs as biomarkers of brain injury in neonatal encephalopathy: an observational cohort study.
Fatima Dakroub, Firas Kobeissy, Stefania Mondello...
https://pubmed.ncbi.nlm.nih.gov/38503820Association of High-Dose Erythropoietin With Circulating Biomarkers and Neurodevelopmental Outcomes Among Neonates With Hypoxic Ischemic Encephalopathy: A Secondary Analysis of the HEAL Randomized Clinical Trial.
Sandra E Juul, Emily Voldal, Bryan A Comstock...
https://pubmed.ncbi.nlm.nih.gov/37418263UCH-L1 and GFAP Serum Levels in Neonates with Hypoxic-Ischemic Encephalopathy: A Single Center Pilot Study.
Martha V Douglas-Escobar, Shelley C Heaton, Jeffrey Bennett...
https://pubmed.ncbi.nlm.nih.gov/25566179Glial fibrillary acidic protein as a biomarker for neonatal hypoxic-ischemic encephalopathy treated with whole-body cooling.
Christopher S Ennen, Thierry A G M Huisman, William J Savage...
https://pubmed.ncbi.nlm.nih.gov/21784396Pediatric reference intervals for serum neurofilament light and glial fibrillary acidic protein using the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) cohort.
Sophie Stukas, Jennifer Cooper, Victoria Higgins...
https://pubmed.ncbi.nlm.nih.gov/37882772Serum GFAP and UCH-L1 for the identification of clinically important traumatic brain injury in children in France: a diagnostic accuracy substudy.
Antoine Puravet, Charlotte Oris, Bruno Pereira...
https://pubmed.ncbi.nlm.nih.gov/39637879Age-Dependent Differences in Blood Levels of Glial Fibrillary Acidic Protein but Not Ubiquitin Carboxy-Terminal Hydrolase L1 in Children.
Rebekah Mannix, Erin Borglund, Alexandra Monashefsky...
https://pubmed.ncbi.nlm.nih.gov/38986044Age specific reference intervals for plasma biomarkers of neurodegeneration and neurotrauma in a Canadian population.
Jennifer G Cooper, Sophie Stukas, Mohammad Ghodsi...
https://pubmed.ncbi.nlm.nih.gov/37884086Serum GFAP and UCH-L1 for prediction of absence of intracranial injuries on head CT (ALERT-TBI): a multicentre observational study.
Jeffrey J Bazarian, Peter Biberthaler, Robert D Welch...
https://pubmed.ncbi.nlm.nih.gov/30054151