[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513897":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":27,"centralContacts":31,"locations":37,"responsibleParty":56,"collaborators":58,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":10,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":10,"maxAge":70,"enrollmentInfo":71,"targetDuration":10,"studyType":74,"phases":10,"briefSummary":75,"conditions":76,"keywords":80,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"University of Wisconsin, Madison","OTHER",[8,14],{"label":9,"type":10,"description":10,"interventionNames":11},"Participants with HIE",null,[12,13],"Device: Visual Evoked Potential (VEP)","Device: Electroretinogram (ERG)",{"label":15,"type":10,"description":10,"interventionNames":16},"Healthy participants",[12,13],[18,23],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"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.",[15,9],{"type":19,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"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.",[15,9],[28],{"name":29,"affiliation":5,"role":30},"Pelin Cengiz, MD","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":10,"email":36},"Alexandra Lindstrom","CONTACT","608-262-2388","aklindstrom2@wisc.edu",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"University of Wisconsin","RECRUITING","Madison","Wisconsin","53705","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-89.40123,43.07305,{"lat":50,"lon":49},[53,55],{"name":33,"role":34,"phone":10,"phoneExt":10,"email":54},"aklinidstrom2@wisc.edu",{"name":29,"role":30,"phone":10,"phoneExt":10,"email":10},{"type":57,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[59],{"name":60,"class":6},"Meriter Foundation","100513897","healthy-little-eyes-100513897",false,"NCT05971446","Healthy Little Eyes","Visual Function as a Novel Outcome Measure Following Neonatal Hypoxic Ischemic Encephalopathy","HIE Neonate Inclusion Criteria:\n\n* Inpatient Neonates diagnosed with HIE\n* Pediatric patients who are less than 78 hours of age at the time of enrollment\n* Participants whose parent\u002Flegal guardian is able to complete consenting process in English\n\nHIE Neonate Exclusion Criteria:\n\n* Participants with prenatally diagnosed or congenital brain and\u002For 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\n* Participants who have a known central nervous system illness other than HIE, including but not limited to congenital brain malformations or congenital hydrocephalus\n* Participants whose parent\u002Flegal guardian is unable to provide informed consent, including participants who are in foster care, participants within state custody, and participants of minor parents\n\nWaisman, AFCH NBFU, or CERU Clinic HIE Patient Inclusion Criteria:\n\n* Pediatric patients who have a diagnosis of HIE and present to the Newborn Follow Up Clinic\n* Pediatric patients who are less than 36 months of age at the time of enrollment\n* Participants whose parent\u002Flegal guardian is able to complete consenting process in English\n\nWaisman, AFCH NBFU, or CERU Clinic HIE Patient Exclusion Criteria:\n\n* Participants with prenatally diagnosed or congenital brain and\u002For 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\n* 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\n* Participants whose parent\u002Flegal guardian is unable to provide informed consent, including participants who are in foster care, participants within state custody, and participants of minor parents\n\nWell Baby Inclusion Criteria:\n\n* Patient in Meriter's Newborn Nursery\n* ≥37 and \\\u003C42 weeks gestational age\n* 5-minute Apgar Score ≥7\n* Occipital Frontal Circumference (OFC) is within average limits for age (\\\u003C97th percentile and \\>3rd percentile)\n\nWell Baby Exclusion Criteria:\n\n* Admitted to the NICU for any reason\n* Known genetic abnormality\n* Diagnosed with HIE\n* Diagnosed with Hypoglycemia\n* Diagnosed with Hyperbilirubinemia requiring phototherapy\n* Identified prenatal exposure to substances, including illicit drugs, alcohol, and\u002For tobacco\n* Known or suspected neonatal infection requiring treatment (e.g., antibiotics)\n* TORCH infections\n* Abnormal newborn hearing screen\n* Abnormal toxicology screening\n* Identified as large for gestational age (LGA) or small for gestational age (SGA)\n* 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\n* Subjects who have a known central nervous system illness or malformation, including but not limited to congenital brain malformations or congenital hydrocephalus\n* Participants whose parent\u002Flegal guardian is unable to provide informed consent, including subjects who are in foster care, subjects within state custody, and subjects of minor parents\n* The attending medical team does not approve",true,"ALL","36 Months",{"count":72,"type":73},125,"ESTIMATED","OBSERVATIONAL","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).\n\nParticipants will undergo up to two eye exam sessions, involving both Visual Evoked Potential (VEP) and Electroretinogram (ERG) exams.",[77,78,79],"Hypoxic-Ischemic Encephalopathy","Neonatal Encephalopathy","Encephalopathy",[81,82,83],"neonatal","visual evoked potential","electroretinogram","2026-05-12",{"date":86,"type":87},"2026-05-14","ACTUAL",{"date":89,"type":87},"2020-02-24",{"date":91,"type":73},"2029-07",{"name":5,"class":6},1]