Clinical trial Recruiting at 1 site Observational Ages Any age to 36 Months

Investigating eye function in babies with brain injury

Official title: Visual Function as a Novel Outcome Measure Following Neonatal Hypoxic Ischemic Encephalopathy

Run by University of Wisconsin, Madison · NCT05971446 · Data updated 2026-11-12

This study is trying to see how eye function in babies with brain injuries affects their development over time.

Quick facts

Study typeObservational
AgesAny age to 36 Months
SexAll
Enrollment125 (estimated)
SponsorUniversity of Wisconsin, Madison
Academic / other
Locations1 site (Madison, Wisconsin)
StatusRecruiting
StartedFebruary 24, 2020
Main results expectedJuly 2027
Study endsJuly 2029
Registry record updatedMay 14, 2026
Trial IDNCT05971446 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are inpatient neonates diagnosed with hypoxic-ischemic encephalopathy who are less than 78 hours old.

Probably not a fit

Patients with congenital brain or eye abnormalities unrelated to HIE or other central nervous system illnesses may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the relationship between eye injury and future development in infants diagnosed with hypoxic-ischemic encephalopathy (HIE). Participants will undergo up to two eye exam sessions, including Visual Evoked Potential (VEP) and Electroretinogram (ERG) tests, to assess retinal and visual cortical function. The study will correlate these eye function results with neurodevelopmental and neuroimaging outcomes over a period of 36 months. Additionally, machine learning will be utilized to predict clinical outcomes based on collected data.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic and treatment strategies for infants with HIE, enhancing their neurodevelopmental outcomes.

How similar studies have gone: While this approach is innovative, similar studies have shown promise in correlating visual function with neurodevelopmental outcomes in neonates.

Who can join: the full rules

Show full inclusion / exclusion 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 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 it's running

  • University of Wisconsin
    Madison, Wisconsin, United States
    Recruiting

Study contacts

  • Principal investigator: Pelin Cengiz, MD — University of Wisconsin, Madison
  • Study coordinator: Alexandra Lindstrom
  • Email: aklindstrom2@wisc.edu
  • Phone: 608-262-2388

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Neonatal Neurological Observation With Video AI

    This study tests a real-time, non-contact video AI system to help monitor brain health in newborns with suspected brain injury during their hospital stay.

    Recruiting Artemis AI Labs · New York, New York and 1 other locations · NCT07628829

  • Testing Levetiracetam for treating neonatal seizures

    This study is testing how much of the medication Levetiracetam is safe to give to newborns with seizures to see if it works better than the standard treatment.

    Recruiting at 5 sites Phase 2 University of California, San Diego · San Diego, California and 5 other locations · NCT05610085

  • Evaluating Sovateltide for treating brain injury in newborns

    This study is testing a new treatment called Sovateltide to see if it can help newborns with brain injuries caused by lack of oxygen during birth.

    Recruiting at 2 sites Phase 2 Pharmazz, Inc. · Mangalore, Karnataka and 3 other locations · NCT05514340

  • Newborn Brain Wave Checker: See if CergenX Wave matches the Sarnat exam

    This study tests whether the CergenX Wave software, which analyzes a newborn's EEG via a small four-electrode setup, can match the standard Sarnat examination in babies with suspected neonatal encephalopathy.

    Recruiting CergenX Limited · Dallas, Texas and 1 other locations · NCT07857070

  • Wireless NIRS Sensor Use in the NICU for Monitoring on Neonates

    A wireless NIRS sensor is tested on infants in the NICU to see how well it stays on and how it notes brain signals when used alongside standard wired sensors.

    Recruiting McGill University Health Centre/Research Institute of the McGill University Health Centre · Montreal, Quebec · NCT07732244

  • Two-week intensive brain-focused therapy program for children with neurodevelopmental and chromosomal conditions

    This program will try a two-week, individualized multimodal neurorehabilitation approach for children about 4–12 years old with neurodevelopmental or chromosomal conditions to see if it improves attention, motor skills, communication, and daily functioning.

    Recruiting Healing Hope International · The Woodlands, Texas · NCT07493096

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.