Healthy Little Eyes

NCT05971446 | Recruiting FDA Device

• 3 other identifiers: 2019-1243SMPH\PEDIATRICS\PICUProtocol Version 6/19/2025
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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

Neonatal Encephalopathy; Encephalopathy; Hypoxic-Ischemic Encephalopathy

Keywords

neonatal; visual evoked potential; electroretinogram

Outcome Measures

Primary Outcomes (9)

• To evaluate the correlation between retinal function and neurodevelopmental outcomes

  The least absolute shrinkage and selection operator technique will be utilized to determine whether ERG measures predict neurodevelopmental outcomes

  Through 30 months of life

• To evaluate the correlation between retinal function and neuroimaging outcomes

  The least absolute shrinkage and selection operator technique will be utilized to determine whether ERG measures predict neuroimaging outcomes

  Within first 5 days of life

• To evaluate the correlation between visual cortical function and neurodevelopmental outcomes

  The least absolute shrinkage and selection operator technique will be utilized to determine whether VEP measures predict neurodevelopmental outcomes

  Through 30 months of life

• To evaluate the correlation between visual cortical function and neuroimaging outcomes

  The least absolute shrinkage and selection operator technique will be utilized to determine whether VEP measures predict neuroimaging outcomes

  Within first 5 days of life

• Compare ERG results between healthy babies and babies with HIE

  The ERG results from healthy babies will be compared to those of babies with HIE

  Within first 5 days of life

• Report Shape of the VEP results for healthy babies and babies with HIE

  The shape of the waveform will be reported as a categorical variable: sharp, slanted, blunt, or multiple peaks

  Within first 5 days of life

• Compare Amplitude of the VEP results between healthy babies and babies with HIE

  The amplitude will be reported as differences in microvolt responses between groups.

  Within first 5 days of life

• Compare Latency of the VEP results between healthy babies and babies with HIE

  The latency will be reported as differences in timing (measured in milliseconds) between groups.

  Within first 5 days of life

• Compare Transocular Shape, Amplitude, and Latency Difference of the VEP results between healthy babies and babies with HIE

  The Transocular Shape Difference will be reported as differences in shape between the two eyes compared across groups, reported as a categorical variable: sharp, slanted, blunt, or multiple peaks.

  Within first 5 days of life

Study Arms (2)

Participants with HIE

Device: Visual Evoked Potential (VEP); Device: Electroretinogram (ERG)

Healthy participants

Device: Visual Evoked Potential (VEP); Device: Electroretinogram (ERG)

Interventions

Visual Evoked Potential (VEP) DEVICE

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.

Healthy participants; Participants with HIE

Electroretinogram (ERG) DEVICE

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.

Healthy participants; Participants with HIE

Eligibility Criteria

• Age: Up to 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

1. HIE Neonates in the NICU at AFCH or Meriter who are less than 78 hours old 2. HIE Neonates at Waisman, AFCH Newborn Follow-up Clinic, or CERU Clinic who are less than 78 hours old 3. Well babies at the Meriter Newborn Nursery who are less than 36 months of age

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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 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
• Patient in Meriter's Newborn Nursery
• ≥37 and \<42 weeks gestational age
• minute Apgar Score ≥7
• Occipital Frontal Circumference (OFC) is within average limits for age (\<97th percentile and \>3rd percentile)
• Admitted to the NICU for any reason
• Known genetic abnormality
• Diagnosed with HIE

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Meriter Foundation: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Brain Diseases

Interventions

Electroretinography

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Pelin Cengiz, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Lindstrom

CONTACT

608-262-2388; aklindstrom2@wisc.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: August 2, 2023
• Study Start: February 24, 2020
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2029
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)