Investigating eye function in babies with brain injury

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

This study is trying to see how eye function in babies with brain injuries affects their development over time.

Quick facts

• Study type: Observational
• Enrollment: 125 (estimated)
• Ages: N/A to 36 Months
• Sex: All
• Sponsor: University of Wisconsin, Madison (other)
• Locations: 1 site (Madison, Wisconsin)
• Trial ID: NCT05971446 on ClinicalTrials.gov

What this trial studies

This observational study aims to explore the relationship between eye injury and future development in infants diagnosed with hypoxic-ischemic encephalopathy (HIE). Participants will undergo up to two eye exam sessions, including Visual Evoked Potential (VEP) and Electroretinogram (ERG) tests, to assess retinal and visual cortical function. The study will correlate these eye function results with neurodevelopmental and neuroimaging outcomes over a period of 36 months. Additionally, machine learning will be utilized to predict clinical outcomes based on collected data.

Who should consider this trial

Good fit: Ideal candidates for this study are inpatient neonates diagnosed with hypoxic-ischemic encephalopathy who are less than 78 hours old.

Not a fit: Patients with congenital brain or eye abnormalities unrelated to HIE or other central nervous system illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic and treatment strategies for infants with HIE, enhancing their neurodevelopmental outcomes.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in correlating visual function with neurodevelopmental outcomes in neonates.

Eligibility 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

Where this trial is running

Madison, Wisconsin

• University of Wisconsin — Madison, Wisconsin, United States (RECRUITING)

Study contacts

• Principal investigator: Pelin Cengiz, MD — University of Wisconsin, Madison
• Study coordinator: Alexandra Lindstrom

Conditions: Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy, Encephalopathy, neonatal, visual evoked potential, electroretinogram