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(904) 244-0411

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

  • Status
    Accepting Candidates
  • Age
    0 Years - 1 Years
  • Sexes
    All
  • Healthy Volunteers
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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.

Details

Protocol number IRB202102111

Eligibility

Inclusion

Exclusion

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

Lead researcher

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.