Recruiting

Observational Study

Sponsor:

University of Wisconsin, Madison

Code:

NCT05971446

Conditions

Hypoxic-Ischemic Encephalopathy

Neonatal Encephalopathy

Encephalopathy

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Accepted

Interventions

Visual Evoked Potential (VEP)

Electroretinogram (ERG)

Study Details

Brief 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).

Participants will undergo up to two eye exam sessions, involving both Visual Evoked Potential (VEP) and Electroretinogram (ERG) exams.

Conditions

Hypoxic-Ischemic Encephalopathy

Neonatal Encephalopathy

Encephalopathy

Study ID

NCT05971446

Start date

Feb 24, 2020

Status verified date

May, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Accepted

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

Study Design

Enrollment

125 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants with HIE

Healthy participants

Interventions

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.

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 measure

  • To evaluate the correlation between retinal function and neurodevelopmental outcomes [ Time Frame: Through 30 months of life ]
  • To evaluate the correlation between retinal function and neuroimaging outcomes [ Time Frame: Within first 5 days of life ]
  • To evaluate the correlation between visual cortical function and neurodevelopmental outcomes [ Time Frame: Through 30 months of life ]
  • To evaluate the correlation between visual cortical function and neuroimaging outcomes [ Time Frame: Within first 5 days of life ]
  • Compare ERG results between healthy babies and babies with HIE [ Time Frame: Within first 5 days of life ]
  • Report Shape of the VEP results for healthy babies and babies with HIE [ Time Frame: Within first 5 days of life ]
  • Compare Amplitude of the VEP results between healthy babies and babies with HIE [ Time Frame: Within first 5 days of life ]
  • Compare Latency of the VEP results between healthy babies and babies with HIE [ Time Frame: Within first 5 days of life ]
  • 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 ]

Central Contacts and Locations

Central contacts

Locations

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53705

Contacts

Alexandra Lindstrom

aklinidstrom2@wisc.edu

Principal Investigator:

Pelin Cengiz, MD

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

  • neonatal
  • visual evoked potential
  • electroretinogram

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-05-14.