Hypoxic-Ischemic Encephalopathy
Conditions
Keywords
Optical Coherence Tomography, Newborn, Infant
Brief summary
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.
Interventions
DEVICEOptical Coherence Tomography
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.
Sponsors
National Eye Institute (NEI)
Duke University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 20 Days
Healthy volunteers
No
Inclusion criteria
Infants are eligible if: * Admitted to the intensive care nursery, outborn or inborn, with a clinical diagnosis of HIE; and with the approval of the neonatologist * A parent or legal guardian provides written informed consent
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retinal injury morphologies on optical coherence tomography | birth to 10 days | 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 |
| Retinal nerve fiber layer thickness on optical coherence tomography | birth to 10 days | Deviation in the retinal nerve fiber layer thickness in the papillomacular bundle: 0 to 150 microns |
| Inner macular layer thickness on optical coherence tomography | birth to 10 days | 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 |
| Clinical hypoxic ischemic encephalopathy score | birth to 6 hours | hypoxic ischemic encephalopathy clinical score, within the first 6 hours of life, based on the modified Sarnat staging scale: mild, moderate or severe |
| MRI brain injury score | from 4 to 14 days after birth | MRI scoring: global score of overall injury \[0-138\] characterized as mild \[0-11\], moderate \[12-32\], or severe \[\>32\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Choroidal thickness on optical coherence tomography | birth to 9 weeks | Deviation in choroidal thickness across macula(500, 1000 and 2000μm from the fovea): 20 to 800 microns |
| Optic nerve head morphology | birth to 9 weeks | optic nerve head elevation and cup as a composite morphology: normal, excavated, elevated, bowing of retinal pigment epithelium |
| thickness of macular nerve fiber layer | birth to 9 weeks | Deviation in nerve fiber layer thickness across macula(500, 1000 and 2000μm from the fovea): 0 to 100 microns |
| thickness of macular ganglion cell layer | birth to 9 weeks | Deviation in ganglion cell layer thickness across macula(500, 1000 and 2000μm from the fovea): 0 to 200 microns |
| thickness of inner nuclear layer | birth to 9 weeks | Deviation in total retinal thickness across macula (500, 1000 and 2000μm from the fovea): 0 to 400 microns |
| thickness of inner plexiform layer | birth to 9 weeks | Deviation in inner plexiform layer thickness across macula (500, 1000 and 2000μm from the fovea): 0 to 100 microns |
| Longitudinal change in retinal injury morphologies on optical coherence tomography | birth to 9 weeks | 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 |
| Longitudinal change in retinal nerve fiber layer thickness on optical coherence tomography | birth to 9 weeks | Deviation in the retinal nerve fiber layer thickness in the papillomacular bundle: 0 to 150 microns |
| Longitudinal change in inner macular layer thickness on optical coherence tomography | birth to 9 weeks | 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 |
| Late clinical hypoxic ischemic encephalopathy score | 1 to 8 days | Composite hypoxic ischemic encephalopathy severity score based on: examination after rewarming, early feeding behavior score, seizure score and electroencephalogram score |
| thickness of photoreceptor layer | birth to 9 weeks | Deviation in total retinal thickness across macula(500, 1000 and 2000μm from the fovea): 0 to 200 microns |
| Total macular layer thickness on optical coherence tomography | birth to 9 weeks | Deviation in total retinal thickness across macula (500, 1000 and 2000μm from the fovea): 0 to 500 microns |
| Center foveal thickness | birth to 9 weeks | Deviation in retinal thickness at the foveal center |
| Center ellipsoid zone thickness | birth to 9 weeks | Deviation in retinal thickness at the foveal center: 0 to 100 microns |
| pattern of MRI injury | from 4 to 14 days after birth | 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. |
Countries
United States
Outcome results
None listed