No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
Up to 36 Months
Sex
Any
Study type
Observational
Participants needed
125 (estimated)
Sponsor
University of Wisconsin, Madison · Other
Who this trial is looking for
This trial is looking for babies with a condition called hypoxic-ischemic encephalopathy (HIE). Participants will have up to two eye exams to help understand how eye health affects their growth and development.
Are You a Good Fit for This Trial?
You may be able to join if
I am a baby diagnosed with HIE.
I am less than 78 hours old.
My parent or guardian can give consent in English.
You may not be able to join if
I have brain or eye problems not related to HIE.
I have a central nervous system illness other than HIE.
My parent or guardian cannot give consent.
I am in foster care or state custody.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The purpose of this research study is to gather more information on how eye injury is related to a baby's future development and see if eye function and brain test results can be used, along with current measures, to better diagnose and treat babies with hypoxic-ischemic encephalopathy (HIE).
Participants will undergo up to two eye exam sessions, involving both Visual Evoked Potential (VEP) and E…
The purpose of this research study is to gather more information on how eye injury is related to a baby's future development and see if eye function and brain test results can be used, along with current measures, to better diagnose and treat babies with hypoxic-ischemic encephalopathy (HIE).
Participants will undergo up to two eye exam sessions, involving both Visual Evoked Potential (VEP) and Electroretinogram (ERG) exams.
Trial Locations
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Facility
City
State
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Status
Eligibility Criteria
HIE Neonate Inclusion Criteria:
* Inpatient Neonates diagnosed with HIE
* Pediatric patients who are less than 78 hours of age at the time of enrollment
* Participants whose parent/legal guardian is able to complete consenting process in English
HIE Neonate Exclusion Criteria:
* Participants with…
HIE Neonate Inclusion Criteria:
* Inpatient Neonates diagnosed with HIE
* Pediatric patients who are less than 78 hours of age at the time of enrollment
* Participants whose parent/legal guardian is able to complete consenting process in English
HIE Neonate Exclusion Criteria:
* Participants with prenatally diagnosed or congenital brain and/or eye abnormalities not associated with HIE, including but not limited to microphthalmia, anophthalmia, congenital cataract, eye or eyelid coloboma, congenital glaucoma, CMV retinitis, optic nerve hypoplasia, aniridia, cryptophthalmos, globe abnormalities
* Participants who have a known central nervous system illness other than HIE, including but not limited to congenital brain malformations or congenital hydrocephalus
* Participants whose parent/legal guardian is unable to provide informed consent, including participants who are in foster care, participants within state custody, and participants of minor parents
Waisman, AFCH NBFU, or CERU Clinic HIE Patient Inclusion Criteria:
* Pediatric patients who have a diagnosis of HIE and present to the Newborn Follow Up Clinic
* Pediatric patients who are less than 36 months of age at the time of enrollment
* Participants whose parent/legal guardian is able to complete consenting process in English
Waisman, AFCH NBFU, or CERU Clinic HIE Patient Exclusion Criteria:
* Participants with prenatally diagnosed or congenital brain and/or eye abnormalities not associated with HIE, including but not limited to microphthalmia, anophthalmia, congenital cataract, eye or eyelid coloboma, congenital glaucoma, CMV retinitis, optic nerve hypoplasia, aniridia, cryptophthalmos, globe abnormalities
* Participants who have a known central nervous system illness not associated with HIE and its complications. Complications may include seizures, hydrocephalus, and stroke, which are NOT exclusionary. Examples of exclusionary conditions include but are not limited to traumatic brain injury outside the perinatal period, meningitis, or diagnosis of brain tumor
* Participants whose parent/legal guardian is unable to provide informed consent, including participants who are in foster care, participants within state custody, and participants of minor parents
Well Baby Inclusion Criteria:
* Patient in Meriter's Newborn Nursery
* ≥37 and \<42 weeks gestational age
* 5-minute Apgar Score ≥7
* Occipital Frontal Circumference (OFC) is within average limits for age (\<97th percentile and \>3rd percentile)
Well Baby Exclusion Criteria:
* Admitted to the NICU for any reason
* Known genetic abnormality
* Diagnosed with HIE
* Diagnosed with Hypoglycemia
* Diagnosed with Hyperbilirubinemia requiring phototherapy
* Identified prenatal exposure to substances, including illicit drugs, alcohol, and/or tobacco
* Known or suspected neonatal infection requiring treatment (e.g., antibiotics)
* TORCH infections
* Abnormal newborn hearing screen
* Abnormal toxicology screening
* Identified as large for gestational age (LGA) or small for gestational age (SGA)
* Participants with prenatally diagnosed or congenital eye abnormalities, including but not limited to microphthalmia, anophthalmia, congenital cataract, eye or eyelid coloboma, congenital glaucoma, CMV retinitis, optic nerve hypoplasia, aniridia, cryptophthalmos, globe abnormalities, and nystagmus
* Subjects who have a known central nervous system illness or malformation, including but not limited to congenital brain malformations or congenital hydrocephalus
* Participants whose parent/legal guardian is unable to provide informed consent, including subjects who are in foster care, subjects within state custody, and subjects of minor parents
* The attending medical team does not approve
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