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Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants

NCT03640494 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 57

Last updated 2021-04-08

No results posted yet for this study

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.

Conditions

  • Hypoxic-Ischemic Encephalopathy

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Cynthia Toth, MD · Duke University

Eligibility

Max Age
20 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-28
Primary Completion
2021-02-28
Completion
2021-02-28

Countries

  • United States

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03640494 on ClinicalTrials.gov