Visual Function as a Novel Outcome Measure Following Neonatal Hypoxic Ischemic Encephalopathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Report Shape of the VEP results for healthy babies and babies with HIE
研究概览
简要总结
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.
详细描述
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:
- Specific Aim 1 will determine the correlation of the ERG results as a measure of the retinal function obtained at around birth, 3, 9, 18 or 30 months of life and neurodevelopmental-neuroimaging outcomes from birth through 36 months.
- Specific Aim 2 will determine the correlation of the VEP as a measure of the visual cortical function obtained at around birth, 3, 9, 18 or 30 months of life and neurodevelopmental-neuroimaging outcomes from birth through 36 months.
- Specific Aim 3 will collect ERG and VEP results from well babies in the Newborn Nursery and compare results to neonates with HIE.
- Specific Aim 4 will determine if machine learning will predict the clinical outcomes using VEP, ERG, and EEG waveform data, as well as MR imaging files (exploratory)
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Report Shape of the VEP results for healthy babies and babies with HIE
时间窗: Within first 5 days of life
The shape of the waveform will be reported as a categorical variable: sharp, slanted, blunt, or multiple peaks
To evaluate the correlation between retinal function and neurodevelopmental outcomes
时间窗: Through 30 months of life
The least absolute shrinkage and selection operator technique will be utilized to determine whether ERG measures predict neurodevelopmental outcomes
To evaluate the correlation between retinal function and neuroimaging outcomes
时间窗: 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
Compare ERG results between healthy babies and babies with HIE
时间窗: Within first 5 days of life
The ERG results from healthy babies will be compared to those of babies with HIE
Compare Amplitude of the VEP results between healthy babies and babies with HIE
时间窗: Within first 5 days of life
The amplitude will be reported as differences in microvolt responses between groups.
To evaluate the correlation between visual cortical function and neuroimaging outcomes
时间窗: 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
To evaluate the correlation between visual cortical function and neurodevelopmental outcomes
时间窗: Through 30 months of life
The least absolute shrinkage and selection operator technique will be utilized to determine whether VEP measures predict neurodevelopmental outcomes
Compare Latency of the VEP results between healthy babies and babies with HIE
时间窗: Within first 5 days of life
The latency will be reported as differences in timing (measured in milliseconds) between groups.
Compare Transocular Shape, Amplitude, and Latency Difference of the VEP results between healthy babies and babies with HIE
时间窗: 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.
次要结局
未报告次要终点