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Baby eye exams may reveal hidden brain injury

NCT ID NCT05971446

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether simple, non-invasive eye tests can help predict brain development in newborns with hypoxic-ischemic encephalopathy (HIE), a type of brain injury caused by lack of oxygen. Researchers will measure eye function using visual evoked potential (VEP) and electroretinogram (ERG) in up to 125 babies. The goal is to see if these tests can be used alongside current methods to better diagnose and treat HIE.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a new way to predict brain development in babies with HIE using simple eye tests.
What could go wrong
This is an early observational study, so it may not find a strong link between eye tests and brain outcomes. Results may not apply to all babies with HIE.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 125 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2020

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

Up to 36 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53705, United States

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