Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-28

Study Completion Date

2021-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypoxic-Ischemic Encephalopathy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Optical Coherence Tomography

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Maximum Eligible Age

20 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No