Hypoxic-Ischemic EncephalopathyNCT05971446
Healthy Little Eyes
An observational study of Hypoxic-Ischemic Encephalopathy and Neonatal Encephalopathy, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages Up to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy, Encephalopathy
- What is being tested?
- Visual Evoked Potential (VEP) and Electroretinogram (ERG)
- Type of treatment
- Medical device
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2020to Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: 1. HIE Neonates in the NICU at AFCH or Meriter who are less than 78 hours old 2. HIE Neonates at Waisman, AFCH Newborn Follow-up Clinic, or CERU Clinic who are less than 78 hours old 3. Well babies at the Meriter Newborn Nursery who are less than 36 months of age
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53705
Alexandra Lindstrom, aklinidstrom2@wisc.edu
Pelin Cengiz, MD
About this study
Official title: Visual Function as a Novel Outcome Measure Following Neonatal Hypoxic Ischemic Encephalopathy
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.
Read the detailed description
Specific Aims/Study Objectives:
In this proposed longitudinal study, the investigators hypothesize that the early visual function findings will correlate with the neurodevelopmental and neuroimaging outcomes in children who sustain HIE. The investigators will test this hypothesis through the following specific aims:
- Specific Aim 1 will determine the correlation of the ERG results as a measure of the retinal function obtained at around birth, 3, 9, 18 or 30 months of life and neurodevelopmental-neuroimaging outcomes from birth through 36 months.
- Specific Aim 2 will determine the correlation of the VEP as a measure of the visual cortical function obtained at around birth, 3, 9, 18 or 30 months of life and neurodevelopmental-neuroimaging outcomes from birth through 36 months.
- Specific Aim 3 will collect ERG and VEP results from well babies in the Newborn Nursery and compare results to neonates with HIE.
- Specific Aim 4 will determine if machine learning will predict the clinical outcomes using VEP, ERG, and EEG waveform data, as well as MR imaging files (exploratory)
As health care providers, the investigators' goal is to develop a noninvasive and novel quantitative tool to improve the neurodevelopmental outcome of neonates and to support them in attaining maximum functional potential in childhood and beyond.
- Being tested
- Visual Evoked Potential (VEP), Electroretinogram (ERG)
- Keywords
- neonatal, visual evoked potential, electroretinogram
- Medical subject headings
- Hypoxia-Ischemia, Brain, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Evoked Potential (VEP)Device
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.
Electroretinogram (ERG)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with HIE | Not described Receives: Device: Visual Evoked Potential (VEP); Device: Electroretinogram (ERG) | |
| Healthy participants | Not described Receives: Device: Visual Evoked Potential (VEP); Device: Electroretinogram (ERG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the correlation between retinal function and neurodevelopmental outcomes
The least absolute shrinkage and selection operator technique will be utilized to determine whether ERG measures predict neurodevelopmental outcomes
Measured: Through 30 months of life
To evaluate the correlation between retinal function and neuroimaging outcomes
The least absolute shrinkage and selection operator technique will be utilized to determine whether ERG measures predict neuroimaging outcomes
Measured: Within first 5 days of life
To evaluate the correlation between visual cortical function and neurodevelopmental outcomes
The least absolute shrinkage and selection operator technique will be utilized to determine whether VEP measures predict neurodevelopmental outcomes
Measured: Through 30 months of life
To evaluate the correlation between visual cortical function and neuroimaging outcomes
The least absolute shrinkage and selection operator technique will be utilized to determine whether VEP measures predict neuroimaging outcomes
Measured: Within first 5 days of life
Compare ERG results between healthy babies and babies with HIE
The ERG results from healthy babies will be compared to those of babies with HIE
Measured: Within first 5 days of life
Report Shape of the VEP results for healthy babies and babies with HIE
The shape of the waveform will be reported as a categorical variable: sharp, slanted, blunt, or multiple peaks
Measured: Within first 5 days of life
Compare Amplitude of the VEP results between healthy babies and babies with HIE
The amplitude will be reported as differences in microvolt responses between groups.
Measured: Within first 5 days of life
Compare Latency of the VEP results between healthy babies and babies with HIE
The latency will be reported as differences in timing (measured in milliseconds) between groups.
Measured: Within first 5 days of life
Compare Transocular Shape, Amplitude, and Latency Difference of the VEP results between healthy babies and babies with HIE
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.
Measured: Within first 5 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start24 Feb 2020
- Primary completionJul 2027 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Meriter Foundation
- Responsible party
- Sponsor
- Investigators
- Pelin Cengiz, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971446
- Sponsor's protocol ID
- 2019-1243
- Other IDs
- SMPH\PEDIATRICS\PICU, Protocol Version 6/19/2025
- Status last verified
- May 2026
- First submitted
- 27 Jun 2023
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Function as a Novel Outcome Measure Following Neonatal Hypoxic Ischemic Encephalopathy
- ClinicalTrials.gov ID
- NCT05971446
- Acronym / sponsor ID
- 2019-1243
- Keywords
- neonatal, visual evoked potential, electroretinogram
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Meriter Foundation
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Specific Aims/Study Objectives:
In this proposed longitudinal study, the investigators hypothesize that the early visual function findings will correlate with the neurodevelopmental and neuroimaging outcomes in children who sustain HIE. The investigators will test this hypothesis through the following specific aims:
- Specific Aim 1 will determine the correlation of the ERG results as a measure of the retinal function obtained at around birth, 3, 9, 18 or 30 months of life and neurodevelopmental-neuroimaging outcomes from birth through 36 months.
- Specific Aim 2 will determine the correlation of the VEP as a measure of the visual cortical function obtained at around birth, 3, 9, 18 or 30 months of life and neurodevelopmental-neuroimaging outcomes from birth through 36 months.
- Specific Aim 3 will collect ERG and VEP results from well babies in the Newborn Nursery and compare results to neonates with HIE.
- Specific Aim 4 will determine if machine learning will predict the clinical outcomes using VEP, ERG, and EEG waveform data, as well as MR imaging files (exploratory)
As health care providers, the investigators' goal is to develop a noninvasive and novel quantitative tool to improve the neurodevelopmental outcome of neonates and to support them in attaining maximum functional potential in childhood and beyond.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with HIE | – | Device: Visual Evoked Potential (VEP), Device: Electroretinogram (ERG) |
| Healthy participants | – | Device: Visual Evoked Potential (VEP), Device: Electroretinogram (ERG) |
Who may qualify
- Ages
- Up to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 1. HIE Neonates in the NICU at AFCH or Meriter who are less than 78 hours old 2. HIE Neonates at Waisman, AFCH Newborn Follow-up Clinic, or CERU Clinic who are less than 78 hours old 3. Well babies at the Meriter Newborn Nursery who are less than 36 months of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Healthy participants, Participants with HIE |
| 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. | Device | Healthy participants, Participants with HIE |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
Related trials for Hypoxic-Ischemic Encephalopathy
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Recruiting
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Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
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The PROTECT-HIE Pilot Trial
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Neuro-MoD: Neuroplasticity With Motor Development
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pelin Cengiz, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxic-Ischemic Encephalopathy and Neonatal Encephalopathy, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Lindstrom (608-262-2388, aklindstrom2@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the correlation between retinal function and neurodevelopmental outcomes (time frame: Through 30 months of life). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.