Central Nervous System Derived Exosomes: A Novel Source of Biomarkers for Neonatal Hypoxic Ischemic Encephalopathy
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StatusAccepting Candidates
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Age0 Years - 1 Years
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SexesAll
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Healthy Volunteers
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
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Mark Hudak, MDNeonatologist
Participate in a study
Here are some general steps to consider when participating in a research study:
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Step1
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
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Step2
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.
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Step3
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.
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Step4
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.