NCT05971446

Healthy Little Eyes

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 125 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 36 Months
• Healthy volunteers: Accepted

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.

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.

Conditions

• Hypoxic-Ischemic Encephalopathy
• Neonatal Encephalopathy
• Encephalopathy

Interventions

Type	Name	Description
DEVICE	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	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.

Timeline

• Start date: 2020-02-24
• Primary completion: 2027-07-01
• Completion: 2029-07-01
• First posted: 2023-08-02
• Last updated: 2025-05-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study