Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants

Hypoxic-Ischemic Encephalopathy Clinical Trial

Official title:

Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03640494
• Other study ID #: Pro00100417
• Secondary ID: 1R21EY029384
• Status: Completed
• Start date: August 28, 2018
• Est. completion date: February 28, 2021

Study information

• Verified date: February 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 20 Days

Eligibility

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.

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Hypoxia
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy
• Ischemia

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Mangalesh 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;25 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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	birth to 9 weeks
Secondary	Center foveal thickness	Deviation in retinal thickness at the foveal center	birth to 9 weeks
Secondary	Center ellipsoid zone thickness	Deviation in retinal thickness at the foveal center: 0 to 100 microns	birth to 9 weeks
Secondary	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.	from 4 to 14 days after birth
Secondary	Choroidal thickness on optical coherence tomography	Deviation in choroidal thickness across macula(500, 1000 and 2000µm from the fovea): 20 to 800 microns	birth to 9 weeks
Secondary	Optic nerve head morphology	optic nerve head elevation and cup as a composite morphology: normal, excavated, elevated, bowing of retinal pigment epithelium	birth to 9 weeks
Secondary	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	birth to 9 weeks
Secondary	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	birth to 9 weeks
Secondary	thickness of inner nuclear layer	Deviation in total retinal thickness across macula (500, 1000 and 2000µm from the fovea): 0 to 400 microns	birth to 9 weeks
Secondary	thickness of inner plexiform layer	Deviation in inner plexiform layer thickness across macula (500, 1000 and 2000µm from the fovea): 0 to 100 microns	birth to 9 weeks
Secondary	thickness of photoreceptor layer	Deviation in total retinal thickness across macula(500, 1000 and 2000µm from the fovea): 0 to 200 microns	birth to 9 weeks
Secondary	Longitudinal change in 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 9 weeks
Secondary	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	birth to 9 weeks
Secondary	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	birth to 9 weeks
Secondary	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	1 to 8 days