Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants
2 other identifiers
observational
57
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2018
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2018
CompletedFirst Posted
Study publicly available on registry
August 21, 2018
CompletedStudy Start
First participant enrolled
August 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2021
CompletedApril 8, 2021
February 1, 2021
2.5 years
August 17, 2018
April 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
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
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
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
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 \[\>32\].
from 4 to 14 days after birth
Secondary Outcomes (15)
Total macular layer thickness on optical coherence tomography
birth to 9 weeks
Center foveal thickness
birth to 9 weeks
Center ellipsoid zone thickness
birth to 9 weeks
pattern of MRI injury
from 4 to 14 days after birth
Choroidal thickness on optical coherence tomography
birth to 9 weeks
- +10 more secondary outcomes
Study Arms (1)
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.
Interventions
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 Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- National Eye Institute (NEI)collaborator
Study Sites (2)
Duke University Health System
Durham, North Carolina, 27705, United States
University of Utah
Salt Lake City, Utah, 84112, United States
Related Publications (2)
Tran-Viet D, Wong BM, Mangalesh S, Maldonado R, Cotten CM, Toth CA. HANDHELD SPECTRAL DOMAIN OPTICAL COHERENCE TOMOGRAPHY IMAGING THROUGH THE UNDILATED PUPIL IN INFANTS BORN PRETERM OR WITH HYPOXIC INJURY OR HYDROCEPHALUS. Retina. 2018 Aug;38(8):1588-1594. doi: 10.1097/IAE.0000000000001735.
PMID: 28570486BACKGROUNDMangalesh S, Tran-Viet D, Pizoli C, Tai V, El-Dairi MA, Chen X, Viehland C, Edwards L, Finkle J, Freedman SF, Toth CA. Subclinical Retinal versus Brain Findings in Infants with Hypoxic Ischemic Encephalopathy. Graefes Arch Clin Exp Ophthalmol. 2020 Sep;258(9):2039-2049. doi: 10.1007/s00417-020-04738-0. Epub 2020 May 29.
PMID: 32472201RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cynthia Toth, MD
Duke University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2018
First Posted
August 21, 2018
Study Start
August 28, 2018
Primary Completion
February 28, 2021
Study Completion
February 28, 2021
Last Updated
April 8, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share