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Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03640494
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Hypoxic-Ischemic Encephalopathy Device: Optical Coherence Tomography

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Study Type : Observational
Estimated Enrollment : 48 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants
Actual Study Start Date : August 28, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Group/Cohort Intervention/treatment
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.
Device: Optical 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   up to 20 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03640494


Contacts
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Contact: Neeru Sarin, MBBS 919-668-5341 neeru.sarin@duke.edu
Contact: Michelle McCall, MCAPM, BA 919-684-0554 michelle.mccall@duke.edu

Locations
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United States, North Carolina
Duke University Health System Recruiting
Durham, North Carolina, United States, 27705
Contact: Neeru Sarin, MBBS    919-668-5341    neeru.sarin@duke.edu   
Contact: Michelle McCall, MCAPM, BA    919-684-0544    michelle.mccall@duke.edu   
Principal Investigator: Cynthia A Toth, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Deborah Y Harrison, MS    801-585-6645    Deborah.Harrison@hsc.utah.edu   
Principal Investigator: Mary Elizabeth Hartnett, MD         
Sponsors and Collaborators
Duke University
National Eye Institute (NEI)
Investigators
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Principal Investigator: Cynthia Toth, MD Duke University

Publications:

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03640494    
Other Study ID Numbers: Pro00100417
1R21EY029384 ( U.S. NIH Grant/Contract )
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Optical Coherence Tomography
Newborn
Infant
Additional relevant MeSH terms:
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Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Ischemia
Hypoxia
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain