Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants

Duke University

Status: Completed

Conditions: Hypoxic-Ischemic Encephalopathy

Treatments: Device: Optical Coherence Tomography

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03640494

Pro00100417

1R21EY029384 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: Under 20 days old

Volunteers: No Healthy Volunteers

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.

Trial design

57 participants in 1 patient group

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.

Treatment:

Device: Optical Coherence Tomography