Healthy Little Eyes

University of Wisconsin (UW)

Status

Enrolling

Conditions

Encephalopathy

Neonatal Encephalopathy

Hypoxic-Ischemic Encephalopathy

Treatments

Device: Electroretinogram (ERG)

Device: Visual Evoked Potential (VEP)

Study type

Observational

Funder types

Other

Identifiers

NCT05971446

2019-1243

SMPH\PEDIATRICS\PICU (Other Identifier)

Protocol Version 4/11/2025 (Other Identifier)

Details and patient eligibility

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.

Full 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.

Enrollment

125 estimated patients

Sex

All

Ages

Under 36 months old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

HIE Neonate 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

HIE Neonate 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

Waisman, AFCH NBFU, or CERU Clinic HIE Patient Inclusion Criteria:

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

Waisman, AFCH NBFU, or CERU Clinic HIE Patient 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 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

Well Baby Inclusion Criteria:

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)

Well Baby Exclusion Criteria:

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