Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants

Completed

Conditions studied: Hypoxic-Ischemic Encephalopathy

In brief

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.

Key facts

Study ID

NCT03640494

Run by

Duke University

People needed

57

Starts

2018-08-28

Expected to finish

2021-02-28

Last updated by the study team

2021-04-08

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Duke University Health System — Durham, North Carolina, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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