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NCT03640494 · ClinicalTrials.gov registry record
Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants
A clinical trial, sponsored by Duke University.
- Completed
- Registry status
- 57
- Enrollment target
NCT03640494: Completed study, sponsored by Duke University.
NCT03640494 is a clinical trial that has completed, run by Duke University. The registered enrollment target is 57 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03640494 has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- 57 participants
- Enrollment target
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.
Primary Outcome
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
Interventions
- DEVICE Optical Coherence Tomography
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2018-08-28 |
| Est. Completion | 2021-02-28 |
What the finished NCT03640494 record still lists
NCT03640494 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 57 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Optical Coherence Tomography is the first listed.
NCT03640494 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03640494 about?
NCT03640494 is a clinical study titled "Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants". 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.
What is the current status of trial NCT03640494?
This trial is currently completed. The enrollment target is 57 participants. The study started on 2018-08-28. Estimated completion is 2021-02-28.
What interventions are being tested in trial NCT03640494?
The interventions under investigation include: Optical Coherence Tomography (DEVICE).
Who is sponsoring clinical trial NCT03640494?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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