NCT05971446 · University of Wisconsin, Madison
Healthy Little Eyes
What this study is about
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).
View original scientific description
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.
Interventions
DEVICE
Visual Evoked Potential (VEP)
Small gold-cup electrodes will be placed on the participant's head using a small dot of adhesive paste. The handheld device is then connected to the electrodes, and the participant's eyes are exposed to a light flicker. Each eye will be tested separately, and while testing one eye, the other eye may be patched.
DEVICE
Electroretinogram (ERG)
Skin electrodes will be placed under each eye. Eyes will then be exposed to a flashing light. Each eye will be tested separately and while testing one eye, the other eye may be patched.
Primary outcome measures
To evaluate the correlation between retinal function and neurodevelopmental outcomes
Time frame: Through 30 months of life
The least absolute shrinkage and selection operator technique will be utilized to determine whether ERG measures predict neurodevelopmental outcomes
To evaluate the correlation between retinal function and neuroimaging outcomes
Time frame: Within first 5 days of life
The least absolute shrinkage and selection operator technique will be utilized to determine whether ERG measures predict neuroimaging outcomes
To evaluate the correlation between visual cortical function and neurodevelopmental outcomes
Time frame: Through 30 months of life
The least absolute shrinkage and selection operator technique will be utilized to determine whether VEP measures predict neurodevelopmental outcomes
To evaluate the correlation between visual cortical function and neuroimaging outcomes
Time frame: Within first 5 days of life
The least absolute shrinkage and selection operator technique will be utilized to determine whether VEP measures predict neuroimaging outcomes
Compare ERG results between healthy babies and babies with HIE
Time frame: Within first 5 days of life
The ERG results from healthy babies will be compared to those of babies with HIE
Report Shape of the VEP results for healthy babies and babies with HIE
Time frame: Within first 5 days of life
The shape of the waveform will be reported as a categorical variable: sharp, slanted, blunt, or multiple peaks
Compare Amplitude of the VEP results between healthy babies and babies with HIE
Time frame: Within first 5 days of life
The amplitude will be reported as differences in microvolt responses between groups.
Compare Latency of the VEP results between healthy babies and babies with HIE
Time frame: Within first 5 days of life
The latency will be reported as differences in timing (measured in milliseconds) between groups.
Compare Transocular Shape, Amplitude, and Latency Difference of the VEP results between healthy babies and babies with HIE
Time frame: Within first 5 days of life
The Transocular Shape Difference will be reported as differences in shape between the two eyes compared across groups, reported as a categorical variable: sharp, slanted, blunt, or multiple peaks.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Madison, Wisconsin
Collaborators
Meriter Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 14, 2026 · Source of record for eligibility and locations