University of Wisconsin
Madison, Wisconsin, 53705, United States
Location status: Recruiting
NCT Number: NCT05971446
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.
Interested in participating?
Request InfoUp to 36 month
All sexes
Observational
Madison, Wisconsin, 53705, United States
Location status: Recruiting
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 outcomes in children who sustain HIE. The investigators will test this hypothesis through the following specific aims:
As health care providers, the investigators' goal is to develop a noninvasive and novel quantitative tool to improve the neurodevelopmental outcome of neonates and to support them in attaining maximum functional potential in childhood and beyond.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
HIE Neonate Inclusion Criteria:
HIE Neonate Exclusion Criteria:
Waisman, AFCH NBFU, or CERU Clinic HIE Patient Inclusion Criteria:
Waisman, AFCH NBFU, or CERU Clinic HIE Patient Exclusion Criteria:
Well Baby Inclusion Criteria:
Well Baby Exclusion Criteria:
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.
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.
Time frame: Through 30 months of life
The least absolute shrinkage and selection operator technique will be utilized to determine whether ERG measures predict neurodevelopmental outcomes
Time frame: Within first 5 days of life
The least absolute shrinkage and selection operator technique will be utilized to determine whether ERG measures predict neuroimaging outcomes
Time frame: Through 30 months of life
The least absolute shrinkage and selection operator technique will be utilized to determine whether VEP measures predict neurodevelopmental outcomes
Time frame: Within first 5 days of life
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 life
The ERG results from healthy babies will be compared to those of babies with HIE
Time frame: Within first 5 days of life
The shape of the waveform will be reported as a categorical variable: sharp, slanted, blunt, or multiple peaks
Time frame: Within first 5 days of life
The amplitude will be reported as differences in microvolt responses between groups.
Time frame: Within first 5 days of life
The latency will be reported as differences in timing (measured in milliseconds) between groups.
Time frame: Within first 5 days of life
The Transocular Shape Difference will be reported as differences in shape between the two eyes compared across groups, reported as a categorical variable: sharp, slanted, blunt, or multiple peaks.
Contact information is provided by the study sponsor or research team.
University of Wisconsin, Madison
Other
Visual Function as a Novel Outcome Measure Following Neonatal Hypoxic Ischemic Encephalopathy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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