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Healthy Little Eyes

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ClinicalTrials.gov Identifier: NCT05971446
Recruitment Status : Recruiting
First Posted : August 2, 2023
Last Update Posted : August 2, 2023
Sponsor:
Collaborator:
Meriter Foundation
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
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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.


Condition or disease Intervention/treatment
Hypoxic-Ischemic Encephalopathy Neonatal Encephalopathy Encephalopathy Device: Visual Evoked Potential (VEP) Device: Electroretinogram (ERG)

Study Design
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Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Visual Function as a Novel Outcome Measure Following Neonatal Hypoxic Ischemic Encephalopathy
Actual Study Start Date : February 24, 2020
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024
Groups and Cohorts
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Group/Cohort Intervention/treatment
Participants with HIE Device: Visual Evoked Potential (VEP)
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.

Device: Electroretinogram (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.
Healthy participants Device: Visual Evoked Potential (VEP)
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.

Device: Electroretinogram (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.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  1. HIE Neonates in the NICU at AFCH or Meriter who are less than 78 hours old
  2. HIE Neonates at Waisman, AFCH Newborn Follow-up Clinic, or CERU Clinic who are less than 78 hours old
  3. Well babies at the Meriter Newborn Nursery who are less than 36 months of age
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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05971446


Contacts
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Contact: Alexandra Lindstrom 608-262-2388 aklindstrom2@wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53705
Contact: Alexandra Lindstrom       aklinidstrom2@wisc.edu   
Principal Investigator: Pelin Cengiz, MD         
Sponsors and Collaborators
University of Wisconsin, Madison
Meriter Foundation
Investigators
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Principal Investigator: Pelin Cengiz, MD University of Wisconsin, Madison
More Information
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT05971446    
Other Study ID Numbers: 2019-1243
SMPH\PEDIATRICS\PICU ( Other Identifier: UW Madison )
Protocol Version 3/31/2023 ( Other Identifier: UW Madison )
First Posted: August 2, 2023    Key Record Dates
Last Update Posted: August 2, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by University of Wisconsin, Madison:
neonatal
visual evoked potential
electroretinogram
Additional relevant MeSH terms:
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Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Hypoxia
Central Nervous System Diseases
Nervous System Diseases
 Signs and Symptoms, Respiratory
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain