Encephalopathy, Hypoxic-Ischemic Encephalopathy, Neonatal Encephalopathy
Conditions
Keywords
neonatal, visual evoked potential, electroretinogram
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.
Interventions
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.
DEVICEElectroretinogram (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.
Sponsors
University of Wisconsin, Madison
Meriter Foundation
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 36 Months
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the correlation between retinal function and neurodevelopmental outcomes | Through 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 outcomes | 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 |
| To evaluate the correlation between visual cortical function and neurodevelopmental outcomes | Through 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 outcomes | 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 |
| Compare ERG results between healthy babies and babies with HIE | Within 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 HIE | Within 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 HIE | Within 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 HIE | Within 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 HIE | 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. |
Countries
United States
Contacts
CONTACTAlexandra Lindstrom
PRINCIPAL_INVESTIGATORPelin Cengiz, MD
University of Wisconsin, Madison
Outcome results
None listed