Status:
RECRUITING
Healthy Little Eyes
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Meriter Foundation
Conditions:
Hypoxic-Ischemic Encephalopathy
Neonatal Encephalopathy
Eligibility:
All Genders
Up to 36 years
Brief Summary
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 curr...
Detailed Description
Specific Aims/Study Objectives: In this proposed longitudinal study, the investigators hypothesize that the early visual function findings will correlate with the neurodevelopmental and neuroimaging ...
Eligibility Criteria
Inclusion
- HIE Neonate
- 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
- 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
Key Trial Info
Start Date :
February 24 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT05971446
Start Date
February 24 2020
End Date
July 1 2029
Last Update
May 20 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Wisconsin
Madison, Wisconsin, United States, 53705