Healthy Little Eyes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 36
SponsorUniversity of Wisconsin, Madison
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Pediatric patients who have a diagnosis of HIE and present to the Newborn Follow Up Clinic
Trial 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
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Visual Evoked Potential (VEP)
DeviceSmall 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.
Electroretinogram (ERG)
DeviceSkin 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.
Treatment groups
125 Participants
are divided into 2 treatment groupsGroup A: Participants with HIE2 interventions
Group B: Healthy participants2 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
Through 30 months of life2
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
Time frame
Within first 5 days of life3
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
Time frame
Through 30 months of life4
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
Time frame
Within first 5 days of lifeSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Wisconsin, Madison
Lead sponsor
Meriter Foundation
Collaborator
Source ClinicalTrials.gov