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| ID | Type | Description | Link |
|---|---|---|---|
| SMPH\PEDIATRICS\PICU | Other Identifier | UW Madison | |
| Protocol Version 6/19/2025 | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| Meriter Foundation | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with HIE |
| ||
| Healthy participants |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the correlation between retinal function and neurodevelopmental outcomes | The least absolute shrinkage and selection operator technique will be utilized to determine whether ERG measures predict neurodevelopmental outcomes | Through 30 months of life |
| To evaluate the correlation between retinal function and neuroimaging outcomes | The least absolute shrinkage and selection operator technique will be utilized to determine whether ERG measures predict neuroimaging outcomes | Within first 5 days of life |
| To evaluate the correlation between visual cortical function and neurodevelopmental outcomes | The least absolute shrinkage and selection operator technique will be utilized to determine whether VEP measures predict neurodevelopmental outcomes | Through 30 months of life |
| To evaluate the correlation between visual cortical function and neuroimaging outcomes | The least absolute shrinkage and selection operator technique will be utilized to determine whether VEP measures predict neuroimaging outcomes | Within first 5 days of life |
| Compare ERG results between healthy babies and babies with HIE | The ERG results from healthy babies will be compared to those of babies with HIE | Within first 5 days of life |
| Report Shape of the VEP results for healthy babies and babies with HIE | The shape of the waveform will be reported as a categorical variable: sharp, slanted, blunt, or multiple peaks | Within first 5 days of life |
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HIE Neonate Inclusion Criteria:
HIE Neonate Exclusion Criteria:
Waisman, AFCH NBFU, or CERU Clinic HIE Patient Inclusion Criteria:
Waisman, AFCH NBFU, or CERU Clinic HIE Patient Exclusion Criteria:
Well Baby Inclusion Criteria:
Well Baby Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandra Lindstrom | Contact | 608-262-2388 | aklindstrom2@wisc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Pelin Cengiz, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Recruiting | Madison | Wisconsin | 53705 | United States |
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| ID | Term |
|---|---|
| D020925 | Hypoxia-Ischemia, Brain |
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004596 | Electroretinography |
| ID | Term |
|---|---|
| D003941 | Diagnostic Techniques, Ophthalmological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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| 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. |
|
| Compare Amplitude of the VEP results between healthy babies and babies with HIE | The amplitude will be reported as differences in microvolt responses between groups. | Within first 5 days of life |
| Compare Latency of the VEP results between healthy babies and babies with HIE | The latency will be reported as differences in timing (measured in milliseconds) between groups. | Within first 5 days of life |
| Compare Transocular Shape, Amplitude, and Latency Difference of the VEP results between healthy babies and babies with HIE | 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. | Within first 5 days of life |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |