Healthy Little Eyes

NCT ID: NCT05971446

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 125 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-24
• Study Completion Date: 2029-07-31

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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants with HIE

Visual Evoked Potential (VEP)

Intervention Type: 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.

Electroretinogram (ERG)

Intervention Type: 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

Visual Evoked Potential (VEP)

Intervention Type: 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.

Electroretinogram (ERG)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

• 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)

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

• 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

• 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

• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Meriter Foundation

OTHER

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pelin Cengiz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin

Madison, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alexandra Lindstrom

Role: CONTACT

aklindstrom2@wisc.edu

608-262-2388

Facility Contacts

Alexandra Lindstrom

Role: primary

aklinidstrom2@wisc.edu

Other Identifiers

SMPH\PEDIATRICS\PICU

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 4/11/2025

Identifier Type: OTHER

Identifier Source: secondary_id

2019-1243

Identifier Type: -

Identifier Source: org_study_id