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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21EY029384 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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The purpose of this study is to develop a novel noninvasive bedside optical coherence tomography (OCT) imaging technique in newborn infants with HIE that improves our ability to assess the range of retinal effects from HIE and to diagnose and monitor treatments of HIE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neonates with a clinical HIE diagnosis | 48 neonates with a clinical diagnosis of HIE will be recruited from the patient populations of Duke University Health System and the University of Utah. All subject will have bedside optical coherence tomography (OCT) imaging performed at various time points while in the intensive care nursery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical Coherence Tomography | Device | This is an observational study in which subjects will be imaged with optical coherence tomography (OCT). OCT systems are optical imaging technology that allow non-contact imaging of the microanatomy of the retina, optic nerve head and retinal blood vessels. The OCT devices are held above (and do not touch) the eye. Unlike visible light from many examination devices, the infrared OCT beam is barely visible to the human eye as it sweeps across the retina. Thus the infant is not disturbed by the light. |
| Measure | Description | Time Frame |
|---|---|---|
| Retinal injury morphologies on optical coherence tomography | Composite injury score from presence or absence of 5 morphologies on optical coherence tomography: 1) cystoid spaces,2) ganglion cell layer abnormality, 3) paracentral acute middle maculopathy, 4) hemorrhages, 5) photoreceptor ellipsoid zone at the fovea | birth to 10 days |
| Retinal nerve fiber layer thickness on optical coherence tomography | Deviation in the retinal nerve fiber layer thickness in the papillomacular bundle: 0 to 150 microns | birth to 10 days |
| Inner macular layer thickness on optical coherence tomography | Deviation in the thickness from internal limiting membrane to outer plexiform layer across the macula (500, 1000 and 2000μm from the fovea): 0 to 500 microns | birth to 10 days |
| Clinical hypoxic ischemic encephalopathy score | hypoxic ischemic encephalopathy clinical score, within the first 6 hours of life, based on the modified Sarnat staging scale: mild, moderate or severe | birth to 6 hours |
| MRI brain injury score | MRI scoring: global score of overall injury [0-138] characterized as mild [0-11], moderate [12-32], or severe [>32]. | from 4 to 14 days after birth |
| Measure | Description | Time Frame |
|---|---|---|
| Total macular layer thickness on optical coherence tomography | Deviation in total retinal thickness across macula (500, 1000 and 2000μm from the fovea): 0 to 500 microns | birth to 9 weeks |
| Center foveal thickness |
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Inclusion Criteria:
Infants are eligible if:
Exclusion Criteria:
Potentially eligible infants will be excluded if:
• Congenital or chromosomal anomaly that has a profound impact on brain or eye development (e.g. anencephaly, congenital cataract or Peter's anomaly) and infants for whom there has been a clinical decision to limit life support.
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Forty-eight participants with a clinical diagnosis of hypoxic ischemic encephalopathy will be recruited and consented into this study from the patient populations of Duke University and the University of Utah neonatal intensive care nurseries.
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Toth, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Health System | Durham | North Carolina | 27705 | United States | ||
| University of Utah |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28570486 | Background | Tran-Viet D, Wong BM, Mangalesh S, Maldonado R, Cotten CM, Toth CA. HANDHELD SPECTRAL DOMAIN OPTICAL COHERENCE TOMOGRAPHY IMAGING THROUGH THE UNDILATED PUPIL IN INFANTS BORN PRETERM OR WITH HYPOXIC INJURY OR HYDROCEPHALUS. Retina. 2018 Aug;38(8):1588-1594. doi: 10.1097/IAE.0000000000001735. | |
| 32472201 | Result | Mangalesh S, Tran-Viet D, Pizoli C, Tai V, El-Dairi MA, Chen X, Viehland C, Edwards L, Finkle J, Freedman SF, Toth CA. Subclinical Retinal versus Brain Findings in Infants with Hypoxic Ischemic Encephalopathy. Graefes Arch Clin Exp Ophthalmol. 2020 Sep;258(9):2039-2049. doi: 10.1007/s00417-020-04738-0. Epub 2020 May 29. |
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| ID | Term |
|---|---|
| D020925 | Hypoxia-Ischemia, Brain |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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Deviation in retinal thickness at the foveal center
| birth to 9 weeks |
| Center ellipsoid zone thickness | Deviation in retinal thickness at the foveal center: 0 to 100 microns | birth to 9 weeks |
| pattern of MRI injury | Patterns of injury characterized descriptively as white matter, focal cortical, deep nuclear brain matter, or global based on the scoring methods of Bednadrek N et al. | from 4 to 14 days after birth |
| Choroidal thickness on optical coherence tomography | Deviation in choroidal thickness across macula(500, 1000 and 2000μm from the fovea): 20 to 800 microns | birth to 9 weeks |
| Optic nerve head morphology | optic nerve head elevation and cup as a composite morphology: normal, excavated, elevated, bowing of retinal pigment epithelium | birth to 9 weeks |
| thickness of macular nerve fiber layer | Deviation in nerve fiber layer thickness across macula(500, 1000 and 2000μm from the fovea): 0 to 100 microns | birth to 9 weeks |
| thickness of macular ganglion cell layer | Deviation in ganglion cell layer thickness across macula(500, 1000 and 2000μm from the fovea): 0 to 200 microns | birth to 9 weeks |
| thickness of inner nuclear layer | Deviation in total retinal thickness across macula (500, 1000 and 2000μm from the fovea): 0 to 400 microns | birth to 9 weeks |
| thickness of inner plexiform layer | Deviation in inner plexiform layer thickness across macula (500, 1000 and 2000μm from the fovea): 0 to 100 microns | birth to 9 weeks |
| thickness of photoreceptor layer | Deviation in total retinal thickness across macula(500, 1000 and 2000μm from the fovea): 0 to 200 microns | birth to 9 weeks |
| Longitudinal change in retinal injury morphologies on optical coherence tomography | Composite injury score from presence or absence of 5 morphologies on optical coherence tomography: 1) cystoid spaces,2) ganglion cell layer abnormality, 3) paracentral acute middle maculopathy, 4) hemorrhages, 5) photoreceptor ellipsoid zone at the fovea | birth to 9 weeks |
| Longitudinal change in retinal nerve fiber layer thickness on optical coherence tomography | Deviation in the retinal nerve fiber layer thickness in the papillomacular bundle: 0 to 150 microns | birth to 9 weeks |
| Longitudinal change in inner macular layer thickness on optical coherence tomography | Deviation in the thickness from internal limiting membrane to outer plexiform layer across the macula (500, 1000 and 2000μm from the fovea): 0 to 500 microns | birth to 9 weeks |
| Late clinical hypoxic ischemic encephalopathy score | Composite hypoxic ischemic encephalopathy severity score based on: examination after rewarming, early feeding behavior score, seizure score and electroencephalogram score | 1 to 8 days |
| Salt Lake City |
| Utah |
| 84112 |
| United States |
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |