Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants

Duke University57 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hypoxic-Ischemic Encephalopathy

Interventions

Optical Coherence TomographyDEVICE

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.

Eligibility

Sex: ALLMax age: 20 Days

Medical Language ↔ Plain English

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.

Locations (2)

Duke University Health System

Durham, North Carolina, United States

University of Utah

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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 \[\>32\].

Time frame: from 4 to 14 days after birth

Secondary Outcomes

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

Time frame: birth to 9 weeks

Center foveal thickness

Data from ClinicalTrials.gov

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Deviation in retinal thickness at the foveal center

Time frame: birth to 9 weeks

Center ellipsoid zone thickness

Deviation in retinal thickness at the foveal center: 0 to 100 microns

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: birth to 9 weeks

Longitudinal change in retinal injury morphologies on optical coherence tomography

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 1 to 8 days