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OpenTrials
Completed

NCT Number: NCT03640494

Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants

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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Key information

Conditions

Hypoxic-Ischemic Encephalopathy Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

Up to 20 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Health System, Durham, North Carolina, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Retinal injury morphologies on optical coherence tomography

    Time frame: 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

  2. Retinal nerve fiber layer thickness on optical coherence tomography

    Time frame: birth to 10 days

    Deviation in the retinal nerve fiber layer thickness in the papillomacular bundle: 0 to 150 microns

  3. Inner macular layer thickness on optical coherence tomography

    Time frame: 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

  4. Clinical hypoxic ischemic encephalopathy score

    Time frame: 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

  5. MRI brain injury score

    Time frame: 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 outcomes

  1. Total macular layer thickness on optical coherence tomography

    Time frame: birth to 9 weeks

    Deviation in total retinal thickness across macula (500, 1000 and 2000μm from the fovea): 0 to 500 microns

  2. Center foveal thickness

    Time frame: birth to 9 weeks

    Deviation in retinal thickness at the foveal center

  3. Center ellipsoid zone thickness

    Time frame: birth to 9 weeks

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

  4. pattern of MRI injury

    Time frame: 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.

  5. Choroidal thickness on optical coherence tomography

    Time frame: birth to 9 weeks

    Deviation in choroidal thickness across macula(500, 1000 and 2000μm from the fovea): 20 to 800 microns

  6. Optic nerve head morphology

    Time frame: birth to 9 weeks

    optic nerve head elevation and cup as a composite morphology: normal, excavated, elevated, bowing of retinal pigment epithelium

  7. thickness of macular nerve fiber layer

    Time frame: birth to 9 weeks

    Deviation in nerve fiber layer thickness across macula(500, 1000 and 2000μm from the fovea): 0 to 100 microns

  8. thickness of macular ganglion cell layer

    Time frame: birth to 9 weeks

    Deviation in ganglion cell layer thickness across macula(500, 1000 and 2000μm from the fovea): 0 to 200 microns

  9. thickness of inner nuclear layer

    Time frame: birth to 9 weeks

    Deviation in total retinal thickness across macula (500, 1000 and 2000μm from the fovea): 0 to 400 microns

  10. thickness of inner plexiform layer

    Time frame: birth to 9 weeks

    Deviation in inner plexiform layer thickness across macula (500, 1000 and 2000μm from the fovea): 0 to 100 microns

  11. thickness of photoreceptor layer

    Time frame: birth to 9 weeks

    Deviation in total retinal thickness across macula(500, 1000 and 2000μm from the fovea): 0 to 200 microns

  12. Longitudinal change in retinal injury morphologies on optical coherence tomography

    Time frame: 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

  13. Longitudinal change in retinal nerve fiber layer thickness on optical coherence tomography

    Time frame: birth to 9 weeks

    Deviation in the retinal nerve fiber layer thickness in the papillomacular bundle: 0 to 150 microns

  14. Longitudinal change in inner macular layer thickness on optical coherence tomography

    Time frame: 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

  15. Late clinical hypoxic ischemic encephalopathy score

    Time frame: 1 to 8 days

    Composite hypoxic ischemic encephalopathy severity score based on: examination after rewarming, early feeding behavior score, seizure score and electroencephalogram score

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 21, 2018
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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