Eye Function Tests for Hypoxic-Ischemic Encephalopathy

Overseen By Alexandra Lindstrom

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Congenital abnormalities, CNS illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how eye injuries in babies might affect their development and whether eye and brain tests can enhance the diagnosis and treatment of babies with hypoxic-ischemic encephalopathy (HIE), a condition caused by a lack of oxygen and blood flow to the brain. Participants will undergo up to two eye exams using special tests to assess how their eyes and brain respond to light. Babies with HIE or healthy newborns who meet specific criteria, such as being full-term and having a normal Apgar score, may qualify for this study. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could improve future care for newborns.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether participants need to stop taking their current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these eye function tests are safe for babies?

Research has shown that both the Electroretinogram (ERG) and Visual Evoked Potential (VEP) tests are generally safe for people, including babies with hypoxic-ischemic encephalopathy (HIE).

The ERG test measures the electrical activity of the retina, the part of the eye that senses light. Studies have not identified any major safety issues with this test. It is well-tolerated and frequently used in clinics to assess eye health.

VEP tests evaluate how the brain responds to visual signals. Research indicates that unusual VEP results can be linked to brain injury, but the test itself remains safe. It helps predict outcomes for newborns at risk of brain injury.

Both tests are non-invasive, meaning they cause no discomfort. They play a crucial role in understanding the connection between eye and brain health in babies with HIE. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Healthy Little Eyes trial because it explores new ways to understand and potentially treat Hypoxic-Ischemic Encephalopathy (HIE) in infants. Unlike existing treatments that focus on supportive care and therapeutic hypothermia, this trial investigates the underlying mechanisms of HIE and how they affect eye health. The trial aims to uncover insights into how HIE impacts vision, potentially leading to innovative approaches for protecting and improving eye health in affected infants. This could pave the way for new preventive strategies or treatments that specifically target vision-related outcomes in HIE, which current options do not address.

What evidence suggests that these eye function tests are effective for diagnosing and treating hypoxic-ischemic encephalopathy?

This trial will compare Electroretinogram (ERG) and Visual Evoked Potential (VEP) tests in two groups: healthy participants and those with hypoxic-ischemic encephalopathy (HIE). Studies have shown that both ERG and VEP tests can reveal how the eyes and brain function in babies with HIE. ERG tests assess the inner eye's performance after HIE, helping to determine injury severity. VEP tests measure the brain's response to visual signals and have proven useful in predicting developmental outcomes. Research shows that issues with VEP results correlate with developmental challenges, highlighting the importance of these tests for understanding a baby's future development. ^{2 5 6 7 8}

Who Is on the Research Team?

Pelin Cengiz, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

Inclusion Criteria

Participants must have a parent/legal guardian who is able to consent in English.

You are an inpatient neonate with HIE.

HIE Neonate

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Initial Assessment

Participants undergo initial eye exams including Visual Evoked Potential (VEP) and Electroretinogram (ERG) exams

Within first 5 days of life

1-2 visits (in-person)

Longitudinal Monitoring

Participants are monitored for neurodevelopmental and neuroimaging outcomes with follow-up assessments at 3, 9, 18, and 30 months

Through 36 months of life

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after initial assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Electroretinogram (ERG)
• Visual Evoked Potential (VEP)

How Is the Trial Designed?

Group I: Participants with HIE Experimental Treatment 2 Interventions

Group II: Healthy participants Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Meriter Foundation

Collaborator

Trials

8

Recruited

3,600+

Meriter Foundation

Collaborator

Trials

2

Recruited

210+

Citations

1.

iovs.arvojournals.org

iovs.arvojournals.org/article.aspx?articleid=2334738

Effect of Hypoxic-Ischemic Encephalopathy (HIE) on ... - IOVS

Results: No significant differences were noted in the a-wave amplitude at a flash intensity of 3 log cd-s/m2 between the two eyes in the HIE injured mice. For ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9905320/

Selectively Compromised Inner Retina Function following ...

Selectively Compromised Inner Retina Function following Hypoxic-Ischemic Encephalopathy in mice: a noninvasive measure of severity of the injury. Onur E Taparli ...

3.

researchgate.net

researchgate.net/publication/396395158_Early_Electroencephalography_and_Amplitude-Integrated_Electroencephalography_for_the_Prediction_of_Neurodevelopmental_Outcomes_in_Neonates_with_Hypoxic_Ischemic_Encephalopathy_A_Systematic_Review_and_

A Systematic Review and Diagnostic Test Accuracy Meta ...

Results A total of 37 HIE infants underwent hypothermia with improved aEEG background activity in 28 (75.7%) neonates, of which 18 (48.6%) ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0197018622001966

Selectively compromised inner retina function following ...

Neonatal hypoxia-ischemia (HI) results in severe inner retina function in mice. The loss of inner retinal function detected post-HI in mice is sex-independent.

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32235122/

Predictors of Outcomes in Hypoxic-Ischemic ...

Results: Forty-seven articles and 3 conference abstracts were included, reporting on 3,072infants of whom 39% died or had an adverse neurodevelopmental outcome.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8102460/

Spectral-domain OCT changes in retina and optic nerve in ...

To evaluate the effect of neonatal hypoxic–ischaemic injury on the retina and the optic nerve and to correlate ocular damage with systemic parameters.

7.

frontiersin.org

frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2021.668909/full

Efficiency Evaluation of Neuroprotection for Therapeutic ...

Here, we report the results of therapeutic hypothermia for moderate to severe HIE, and follow-up neurodevelopmental outcomes at the 28th day ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05971446?cond=encephalopathy&viewType=Table&rank=5

Study Details | NCT05971446 | Healthy Little Eyes

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 ( ...