Actively Recruiting
Visual Function as a Novel Outcome Measure Following Neonatal Hypoxic Ischemic Encephalopathy
Led by University of Wisconsin, Madison · Updated on 2026-05-14
125
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
University of Wisconsin, Madison
Lead Sponsor
M
Meriter Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to better understand how eye injuries relate to a baby's future development, focusing on babies with hypoxic-ischemic encephalopathy (HIE). The study explores whether eye function tests and brain test results can improve diagnosis and treatment for these babies. It is a longitudinal observational study that tracks visual and brain outcomes in children with HIE compared to healthy babies. Participants will undergo eye exams including Visual Evoked Potential (VEP) and Electroretinogram (ERG) tests. These involve placing electrodes on the head or skin around the eyes while exposing the eyes to light flickers. Each eye is tested separately, and some babies without HIE are also tested as a comparison group. Data will be collected at birth and multiple points up to 36 months of age. During the study, babies will have up to two eye exam sessions and their neurodevelopment and neuroimaging outcomes will be monitored through 30 months of life. Researchers will analyze eye function, brain imaging, and developmental tests to find correlations. The goal is to develop new, noninvasive tools that help improve long-term outcomes for babies affected by HIE.
CONDITIONS
Brief Title
Healthy Little Eyes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Neonates diagnosed with hypoxic-ischemic encephalopathy (HIE) who are less than 78 hours old at enrollment
- Pediatric patients under 36 months of age with a diagnosis of HIE presenting to follow-up clinics
- Healthy newborns in the Newborn Nursery who are at least 37 weeks and less than 42 weeks gestational age
- Healthy newborns with a 5-minute Apgar Score of 7 or higher
- Healthy newborns with head circumference within average limits (between 3rd and 97th percentile)
- Parent or legal guardian able to complete consenting process in English
You will not qualify if you...
- Babies with prenatally diagnosed or congenital brain or eye abnormalities unrelated to HIE, such as microphthalmia, anophthalmia, congenital cataract, coloboma, congenital glaucoma, CMV retinitis, optic nerve hypoplasia, aniridia, cryptophthalmos, globe abnormalities, or nystagmus
- Known central nervous system illness other than HIE, including congenital brain malformations or hydrocephalus
- Participants whose parent or legal guardian cannot provide informed consent, including those in foster care, state custody, or with minor parents
- Healthy newborns admitted to NICU for any reason
- Healthy newborns with known genetic abnormalities, diagnosed HIE, hypoglycemia, hyperbilirubinemia requiring phototherapy, prenatal exposure to substances, neonatal infections requiring treatment, TORCH infections, abnormal hearing or toxicology screens
- Newborns identified as large or small for gestational age
- Cases where attending medical team does not approve participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 78 hours for neonates with HIE, or at birth for healthy newborns
Participants are screened for eligibility to participate in the trial.
1 screening visit (in-person)
Duration - Within the first 5 days of life for neonates, and at birth for healthy newborns
Participants undergo visual function tests including Visual Evoked Potential (VEP) and Electroretinogram (ERG) to assess retinal and visual cortical function.
1 to 2 visits depending on cohort assignment
Duration - Up to 30 months
Participants have follow-up assessments of visual function and neurodevelopmental outcomes through 30 months of life.
Multiple visits around 3, 9, 18, and 30 months of life
Trial Site Locations
Total: 1 location
1
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
A
Alexandra Lindstrom
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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