Actively Recruiting

Age: 0 - 36Months
All Genders
Healthy Volunteers
NCT05971446

Healthy Little Eyes

Led by University of Wisconsin, Madison · Updated on 2026-05-14

125

Participants Needed

1

Research Sites

487 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

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

Official Title

Healthy Little Eyes

Who Can Participate

Age: 0 - 36Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Inpatient neonates diagnosed with hypoxic-ischemic encephalopathy (HIE)
  • Pediatric patients less than 78 hours old at enrollment
  • Parent or legal guardian able to complete consent in English
  • Pediatric patients diagnosed with HIE presenting to follow-up clinics
  • Pediatric patients younger than 36 months at enrollment
  • Healthy newborns in Meriter's Newborn Nursery
  • Gestational age between 37 and less than 42 weeks
  • 5-minute Apgar score of 7 or higher
  • Occipital Frontal Circumference within average limits (3rd to less than 97th percentile)
Not Eligible

You will not qualify if you...

  • Prenatally diagnosed or congenital brain or eye abnormalities not related to HIE
  • Known central nervous system illnesses other than HIE
  • Parent or legal guardian unable to provide informed consent (including foster care, state custody, or minor parents)
  • Admission to NICU for any reason (healthy babies)
  • Known genetic abnormalities
  • Diagnosed with hypoglycemia or hyperbilirubinemia requiring phototherapy
  • Prenatal exposure to substances like illicit drugs, alcohol, or tobacco
  • Neonatal infections requiring treatment
  • TORCH infections
  • Abnormal newborn hearing or toxicology screening
  • Large or small for gestational age
  • Eye abnormalities such as microphthalmia, anophthalmia, congenital cataract, congenital glaucoma, optic nerve hypoplasia, nystagmus, and others
  • Central nervous system malformations or illnesses such as brain malformations or hydrocephalus
  • Lack of approval from the attending medical team

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Wisconsin

Madison, Wisconsin, United States, 53705

Actively Recruiting

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Research Team

A

Alexandra Lindstrom

CONTACT

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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