RECRUITING

Healthy Little Eyes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Visual Function as a Novel Outcome Measure Following Neonatal Hypoxic Ischemic Encephalopathy

Quick Facts

Study Start:2020-02-24
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05971446

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 36 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Inpatient Neonates diagnosed with HIE
  2. * Pediatric patients who are less than 78 hours of age at the time of enrollment
  3. * Participants whose parent/legal guardian is able to complete consenting process in English
  1. * 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
  2. * Participants who have a known central nervous system illness other than HIE, including but not limited to congenital brain malformations or congenital hydrocephalus
  3. * 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

Contacts and Locations

Study Contact

Alexandra Lindstrom
CONTACT
608-262-2388
aklindstrom2@wisc.edu

Principal Investigator

Pelin Cengiz, MD
PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison

Study Locations (Sites)

University of Wisconsin
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

  • Pelin Cengiz, MD, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-24
Study Completion Date2027-07

Study Record Updates

Study Start Date2020-02-24
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

  • neonatal
  • visual evoked potential
  • electroretinogram

Additional Relevant MeSH Terms

  • Hypoxic-Ischemic Encephalopathy
  • Neonatal Encephalopathy
  • Encephalopathy