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NCT Number: NCT05971446

Healthy Little Eyes

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.

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Key information

Age range

Up to 36 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location status: Recruiting

Location contact

Alexandra Lindstrom

CONTACT

[email protected]

Pelin Cengiz, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. To evaluate the correlation between retinal function and neurodevelopmental outcomes

    Time frame: Through 30 months of life

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

  2. To evaluate the correlation between retinal function and neuroimaging outcomes

    Time frame: Within first 5 days of life

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

  3. To evaluate the correlation between visual cortical function and neurodevelopmental outcomes

    Time frame: Through 30 months of life

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

  4. To evaluate the correlation between visual cortical function and neuroimaging outcomes

    Time frame: Within first 5 days of life

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

  5. Compare ERG results between healthy babies and babies with HIE

    Time frame: Within first 5 days of life

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

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

    Time frame: Within first 5 days of life

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

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

    Time frame: Within first 5 days of life

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

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

    Time frame: Within first 5 days of life

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

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

    Time frame: Within first 5 days of life

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Lindstrom

CONTACT

[email protected]

608-262-2388

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Meriter Foundation

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2029
First posted
Aug 2, 2023
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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