Healthy Little Eyes

Hypoxic-Ischemic Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05971446
• Other study ID #: 2019-1243
• Secondary ID: SMPH\PEDIATRICS\
• Status: Recruiting
• Start date: February 24, 2020
• Est. completion date: July 2024

Study information

• Verified date: July 2023
• Source: University of Wisconsin, Madison
• Contact: Alexandra Lindstrom
• Phone: 608-262-2388
• Email: aklindstrom2[@]wisc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 36 Months

Eligibility

HIE Neonate Inclusion Criteria:

• 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 Criteria:

• 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 Exclusion Criteria:

• 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 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

• 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

Well Baby Inclusion Criteria:

• Patient in Meriter's Newborn Nursery

• =37 and <42 weeks gestational age

• 5-minute Apgar Score =7

• Occipital Frontal Circumference (OFC) is within average limits for age (<97th percentile and >3rd percentile)

Well Baby Exclusion Criteria:

• Admitted to the NICU for any reason

• Known genetic abnormality

• Diagnosed with HIE

• Diagnosed with Hypoglycemia

• Diagnosed with Hyperbilirubinemia requiring phototherapy

• Identified prenatal exposure to substances, including illicit drugs, alcohol, and/or tobacco

• Known or suspected neonatal infection requiring treatment (e.g., antibiotics)

• TORCH infections

• Abnormal newborn hearing screen

• Abnormal toxicology screening

• Identified as large for gestational age (LGA) or small for gestational age (SGA)

• 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

• Subjects who have a known central nervous system illness or malformation, including but not limited to congenital brain malformations or congenital hydrocephalus

• Participants whose parent/legal guardian is unable to provide informed consent, including subjects who are in foster care, subjects within state custody, and subjects of minor parents

• The attending medical team does not approve

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Encephalopathy
• Hypoxia
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy
• Neonatal Encephalopathy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Meriter Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the correlation between retinal function and neurodevelopmental outcomes	The least absolute shrinkage and selection operator technique will be utilized to determine whether ERG measures predict neurodevelopmental outcomes	Through 30 months of life
Primary	To evaluate the correlation between retinal function and neuroimaging outcomes	The least absolute shrinkage and selection operator technique will be utilized to determine whether ERG measures predict neuroimaging outcomes	Within first 5 days of life
Primary	To evaluate the correlation between visual cortical function and neurodevelopmental outcomes	The least absolute shrinkage and selection operator technique will be utilized to determine whether VEP measures predict neurodevelopmental outcomes	Through 30 months of life
Primary	To evaluate the correlation between visual cortical function and neuroimaging outcomes	The least absolute shrinkage and selection operator technique will be utilized to determine whether VEP measures predict neuroimaging outcomes	Within first 5 days of life
Primary	Compare ERG results between healthy babies and babies with HIE	The ERG results from healthy babies will be compared to those of babies with HIE	Within first 5 days of life
Primary	Report Shape of the VEP results for healthy babies and babies with HIE	The shape of the waveform will be reported as a categorical variable: sharp, slanted, blunt, or multiple peaks	Within first 5 days of life
Primary	Compare Amplitude of the VEP results between healthy babies and babies with HIE	The amplitude will be reported as differences in microvolt responses between groups.	Within first 5 days of life
Primary	Compare Latency of the VEP results between healthy babies and babies with HIE	The latency will be reported as differences in timing (measured in milliseconds) between groups.	Within first 5 days of life
Primary	Compare Transocular Shape, Amplitude, and Latency Difference of the VEP results between healthy babies and babies with HIE	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.	Within first 5 days of life