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NCT05971446

Healthy Little Eyes

Recruiting
Not specifiedUp to 36Observational
University of Wisconsin, Madison
~125 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:Visual Evoked Potential (VEP)Electroretinogram (ERG)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the correlation between retinal function and neurodevelopmental outcomes
Measured over Through 30 months of life
+8 more outcomes measured

Conditions

Hypoxic-Ischemic Encephalopathy
Neonatal Encephalopathy
Encephalopathy

Explore related trials

Hypoxic Ischemic EncephalopathyNeonatal Encephalopathy

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Pelin Cengiz, MD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

Who to contact

Alexandra Lindstrom
[email protected]
608-262-2388
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Eligibility criteria

Inclusion

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

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

What this trial measures

  • To evaluate the correlation between retinal function and neurodevelopmental outcomesThrough 30 months of life

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

  • To evaluate the correlation between retinal function and neuroimaging outcomesWithin first 5 days of life

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

  • To evaluate the correlation between visual cortical function and neurodevelopmental outcomesThrough 30 months of life

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

  • To evaluate the correlation between visual cortical function and neuroimaging outcomesWithin first 5 days of life

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

  • Compare ERG results between healthy babies and babies with HIEWithin first 5 days of life

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

  • Report Shape of the VEP results for healthy babies and babies with HIEWithin first 5 days of life

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

  • Compare Amplitude of the VEP results between healthy babies and babies with HIEWithin first 5 days of life

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

  • Compare Latency of the VEP results between healthy babies and babies with HIEWithin first 5 days of life

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

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