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
Qualifiers
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 design
Treatments tested in this trial
- Visual Evoked Potential (VEP)
- Electroretinogram (ERG)
Treatment groups
125 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Wisconsin, Madison
Lead sponsor
Meriter Foundation
Collaborator
Source ClinicalTrials.gov