Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-20 @ 4:28 PM
Study NCT ID:
NCT03640494
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2018-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020925', 'term': 'Hypoxia-Ischemia, Brain'}], 'ancestors': [{'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002534', 'term': 'Hypoxia, Brain'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000860', 'term': 'Hypoxia'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-06', 'studyFirstSubmitDate': '2018-08-17', 'studyFirstSubmitQcDate': '2018-08-17', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retinal injury morphologies on optical coherence tomography', 'timeFrame': 'birth to 10 days', 'description': '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'}, {'measure': 'Retinal nerve fiber layer thickness on optical coherence tomography', 'timeFrame': 'birth to 10 days', 'description': 'Deviation in the retinal nerve fiber layer thickness in the papillomacular bundle: 0 to 150 microns'}, {'measure': 'Inner macular layer thickness on optical coherence tomography', 'timeFrame': 'birth to 10 days', 'description': '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'}, {'measure': 'Clinical hypoxic ischemic encephalopathy score', 'timeFrame': 'birth to 6 hours', 'description': 'hypoxic ischemic encephalopathy clinical score, within the first 6 hours of life, based on the modified Sarnat staging scale: mild, moderate or severe'}, {'measure': 'MRI brain injury score', 'timeFrame': 'from 4 to 14 days after birth', 'description': 'MRI scoring: global score of overall injury \\[0-138\\] characterized as mild \\[0-11\\], moderate \\[12-32\\], or severe \\[\\>32\\].'}], 'secondaryOutcomes': [{'measure': 'Total macular layer thickness on optical coherence tomography', 'timeFrame': 'birth to 9 weeks', 'description': 'Deviation in total retinal thickness across macula (500, 1000 and 2000μm from the fovea): 0 to 500 microns'}, {'measure': 'Center foveal thickness', 'timeFrame': 'birth to 9 weeks', 'description': 'Deviation in retinal thickness at the foveal center'}, {'measure': 'Center ellipsoid zone thickness', 'timeFrame': 'birth to 9 weeks', 'description': 'Deviation in retinal thickness at the foveal center: 0 to 100 microns'}, {'measure': 'pattern of MRI injury', 'timeFrame': 'from 4 to 14 days after birth', 'description': '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.'}, {'measure': 'Choroidal thickness on optical coherence tomography', 'timeFrame': 'birth to 9 weeks', 'description': 'Deviation in choroidal thickness across macula(500, 1000 and 2000μm from the fovea): 20 to 800 microns'}, {'measure': 'Optic nerve head morphology', 'timeFrame': 'birth to 9 weeks', 'description': 'optic nerve head elevation and cup as a composite morphology: normal, excavated, elevated, bowing of retinal pigment epithelium'}, {'measure': 'thickness of macular nerve fiber layer', 'timeFrame': 'birth to 9 weeks', 'description': 'Deviation in nerve fiber layer thickness across macula(500, 1000 and 2000μm from the fovea): 0 to 100 microns'}, {'measure': 'thickness of macular ganglion cell layer', 'timeFrame': 'birth to 9 weeks', 'description': 'Deviation in ganglion cell layer thickness across macula(500, 1000 and 2000μm from the fovea): 0 to 200 microns'}, {'measure': 'thickness of inner nuclear layer', 'timeFrame': 'birth to 9 weeks', 'description': 'Deviation in total retinal thickness across macula (500, 1000 and 2000μm from the fovea): 0 to 400 microns'}, {'measure': 'thickness of inner plexiform layer', 'timeFrame': 'birth to 9 weeks', 'description': 'Deviation in inner plexiform layer thickness across macula (500, 1000 and 2000μm from the fovea): 0 to 100 microns'}, {'measure': 'thickness of photoreceptor layer', 'timeFrame': 'birth to 9 weeks', 'description': 'Deviation in total retinal thickness across macula(500, 1000 and 2000μm from the fovea): 0 to 200 microns'}, {'measure': 'Longitudinal change in retinal injury morphologies on optical coherence tomography', 'timeFrame': 'birth to 9 weeks', 'description': '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'}, {'measure': 'Longitudinal change in retinal nerve fiber layer thickness on optical coherence tomography', 'timeFrame': 'birth to 9 weeks', 'description': 'Deviation in the retinal nerve fiber layer thickness in the papillomacular bundle: 0 to 150 microns'}, {'measure': 'Longitudinal change in inner macular layer thickness on optical coherence tomography', 'timeFrame': 'birth to 9 weeks', 'description': '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'}, {'measure': 'Late clinical hypoxic ischemic encephalopathy score', 'timeFrame': '1 to 8 days', 'description': 'Composite hypoxic ischemic encephalopathy severity score based on: examination after rewarming, early feeding behavior score, seizure score and electroencephalogram score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Optical Coherence Tomography', 'Newborn', 'Infant'], 'conditions': ['Hypoxic-Ischemic Encephalopathy']}, 'referencesModule': {'references': [{'pmid': '28570486', 'type': 'BACKGROUND', '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.'}, {'pmid': '32472201', 'type': 'RESULT', 'citation': '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;258(9):2039-2049. doi: 10.1007/s00417-020-04738-0. Epub 2020 May 29.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '20 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nInfants are eligible if:\n\n* Admitted to the intensive care nursery, outborn or inborn, with a clinical diagnosis of HIE; and with the approval of the neonatologist\n* A parent or legal guardian provides written informed consent\n\nExclusion Criteria:\n\nPotentially eligible infants will be excluded if:\n\n• 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."}, 'identificationModule': {'nctId': 'NCT03640494', 'briefTitle': 'Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants', 'orgStudyIdInfo': {'id': 'Pro00100417'}, 'secondaryIdInfos': [{'id': '1R21EY029384', 'link': 'https://reporter.nih.gov/quickSearch/1R21EY029384', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neonates with a clinical HIE diagnosis', 'description': '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.', 'interventionNames': ['Device: Optical Coherence Tomography']}], 'interventions': [{'name': 'Optical Coherence Tomography', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Neonates with a clinical HIE diagnosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Health System', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Cynthia Toth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Eye Institute (NEI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}