Hypoxic-Ischemic EncephalopathyNCT03640494
Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants
An observational study of Hypoxic-Ischemic Encephalopathy, run by Duke University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 20 days
- Conditions the study is for
- Hypoxic-Ischemic Encephalopathy
- What is being tested?
- Optical Coherence Tomography
- Type of treatment
- Medical device
- How many people
- 57 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Aug 2018to 28 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 20 days
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Health System
Durham, North Carolina, 27705
University of Utah
Salt Lake City, Utah, 84112
About this study
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.
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Being tested
- Optical Coherence Tomography
- Keywords
- Optical Coherence Tomography, Newborn, Infant
- Medical subject headings
- Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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].
Measured: from 4 to 14 days after birth
Secondary outcomes (15)
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
Measured: birth to 9 weeks
Center foveal thickness
Deviation in retinal thickness at the foveal center
Measured: birth to 9 weeks
Center ellipsoid zone thickness
Deviation in retinal thickness at the foveal center: 0 to 100 microns
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: birth to 9 weeks
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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 to 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start28 Aug 2018
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypoxic-Ischemic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Cynthia Toth, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640494
- Sponsor's protocol ID
- Pro00100417
- Other IDs
- 1R21EY029384
- Status last verified
- Feb 2021
- First submitted
- 17 Aug 2018
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28570486Mangalesh 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.
PubMed 32472201
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants
- ClinicalTrials.gov ID
- NCT03640494
- Acronym / sponsor ID
- Pro00100417
- Conditions
- Hypoxic-Ischemic Encephalopathy
- Keywords
- Optical Coherence Tomography, Newborn, Infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates with a clinical HIE diagnosis | – | Device: Optical Coherence Tomography48 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. |
Who may qualify
- Ages
- Up to 20 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical Coherence TomographyThis 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. | Device | Neonates with a clinical HIE diagnosis |
Primary outcome
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
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
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
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
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].
15 secondary outcomes
Total macular layer thickness on optical coherence tomography
Time frame: birth to 9 weeks
Center foveal thickness
Time frame: birth to 9 weeks
Center ellipsoid zone thickness
Time frame: birth to 9 weeks
pattern of MRI injury
Time frame: from 4 to 14 days after birth
Choroidal thickness on optical coherence tomography
Time frame: birth to 9 weeks
Optic nerve head morphology
Time frame: birth to 9 weeks
thickness of macular nerve fiber layer
Time frame: birth to 9 weeks
thickness of macular ganglion cell layer
Time frame: birth to 9 weeks
thickness of inner nuclear layer
Time frame: birth to 9 weeks
thickness of inner plexiform layer
Time frame: birth to 9 weeks
thickness of photoreceptor layer
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
Time frame: birth to 9 weeks
Longitudinal change in inner macular layer thickness on optical coherence tomography
Time frame: birth to 9 weeks
Late clinical hypoxic ischemic encephalopathy score
Time frame: 1 to 8 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Background: PubMed 28570486Tran-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.
- Results publication: PubMed 32472201Mangalesh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Toth, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxic-Ischemic Encephalopathy, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal injury morphologies on optical coherence tomography (time frame: birth to 10 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03640494, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.