Clinical Research Details

Clinical Research

Central Nervous System Derived Exosomes: A Novel Source of Biomarkers for Neonatal Hypoxic Ischemic Encephalopathy

Study Description

The purpose of this research study is to look at biomarkers that come from the baby’s blood and see if these biomarkers are associated with brain injury or if they can predict brain injury.
Biomarkers are particles found in blood or other body tissues and the increase or decrease of
these markers in the blood can be associated with a disease process.

Your child may qualify for this study if your child was diagnosed with hypoxic ischemic
encephalopathy (HIE) at birth and is receiving hypothermia (cooling) therapy. HIE is a
medical condition that can be a result of low oxygen to the brain. Some babies diagnosed with HIE have brain injury, while others do not. This study is trying to learn which babies will have a brain injury and how the brain injury can be predicted.

If you choose to participate, you will be a part of this study for the duration of your hospitalization. Your child will be involved in this study for up to 3 years. We will collect blood samples only in the first 3 days of life, but information about your baby’s medical condition will be reviewed from your baby’s chart up to 3 years.

Inclusion/Exclusion Criteria



Gestational age ³ 36 weeks AND birthweight ³ 1.8 kg AND £ 6 hours from insult

Lethal Chromosome Abnormality

Seizures or a minimum of 3 of 6 HIE clinical criteria

Severe Intrauterine Growth Restriction

One or More of the following predictors of severe HIE

  • pH £ 7.0 with base deficit (BD) ³16 (arterial BG)
  • pH 7.01- 7.15 with BD 10- 15.9
  • No blood gas with acute perinatal event (cord prolapse, uterine rupture, etc.
  • APGAR score 5 at 10 minutes
  • Assisted ventilation at birth for 10 minutes.

Grade III or IV Intracranial Hemorrhage

Sepsis Evaluation with clinical and laboratory signs of sepsis

Open Enrollment

Contact Name: Kim Barnette
Contact Phone: (904) 244-5566
Contact Email:


Mark L. Hudak, M.D.