Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Interventions
- Device: Optical Coherence Tomography
- Registration Number
- NCT03640494
- Lead Sponsor
- Duke University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
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
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Neonates with a clinical HIE diagnosis Optical Coherence Tomography 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.
- Primary Outcome Measures
Name Time Method 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 \[\>32\].
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
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
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
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
- Secondary Outcome Measures
Name Time Method 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
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
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
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
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.
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
Center foveal thickness birth to 9 weeks Deviation in retinal thickness at the foveal center
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
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
Center ellipsoid zone thickness birth to 9 weeks Deviation in retinal thickness at the foveal center: 0 to 100 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
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
Trial Locations
- Locations (2)
Duke University Health System
🇺🇸Durham, North Carolina, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States