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NCT04995341 · ClinicalTrials.gov registry record · NA
Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)
A NA study of Retinopathy of Prematurity, sponsored by Duke University.
- Recruiting
- Registry status
- NA
- Development phase
- 236
- Enrollment target
- 2
- Study locations
NCT04995341 is a NA study of Retinopathy of Prematurity that is actively recruiting participants, run by Duke University. The registered enrollment target is 236 participants, below the 335-participant average among 7 other Retinopathy of Prematurity trials with a reported enrollment target (30% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT04995341, a NA study of Retinopathy of Prematurity, is actively recruiting participants, sponsored by Duke University.
- RECRUITING
- Registry status
- NA
- Development phase
- 236 participants
- Enrollment target
- 2
- Study locations
Study Summary
Retinopathy of prematurity (ROP) is a disorder of development of the neural retina and its vasculature that can impact vision in vulnerable preterm neonates for a lifetime. This study tests high-speed optical coherence tomography (OCT) technology compared to conventional color photographs at the bedside of very preterm infants in the intensive care nursery, to characterize previously unseen abnormalities that can predict a need for referral for ROP treatment, or poor visual or neurological development later in life, up to pre-school age. Our long-term goal is to help improve preterm infant health and vision via objective bedside imaging and analysis that characterizes early critical indicators of ROP, and poor visual function and neurological development, which will rapidly translate to better early intervention and improved future care.
Conditions Studied
Interventions
- DEVICE Investigational ultracompact OCT and OCTA system
- DEVICE retinal photographs
Study Locations (2)
North Carolina
- Duke University Eye Center - Durham
Pennsylvania
- University of Pennsylvania, Center for Preventive Ophthalmology and Biostatistics - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 236 participants |
| Start Date | 2021-08-16 |
| Est. Completion | 2026-03-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04995341
The ClinicalTrials.gov registry entry for NCT04995341 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 236 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 335-participant average among 7 other Retinopathy of Prematurity trials with a reported enrollment target (30% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Retinopathy of Prematurity appearing as the primary indexed condition, and to 2 interventions - of which Investigational ultracompact OCT and OCTA system is the first listed.
NCT04995341 reports 2 study locations spanning 2 distinct geographic areas - top geographies include North Carolina, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04995341 about?
NCT04995341 is a clinical study titled "Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)". Retinopathy of prematurity (ROP) is a disorder of development of the neural retina and its vasculature that can impact vision in vulnerable preterm neonates for a lifetime. This study tests high-speed optical coherence tomography (OCT) technology compared to conventional color photographs at the bed...
What is the current status of trial NCT04995341?
This trial is currently recruiting. It is a NA study. The enrollment target is 236 participants. The study started on 2021-08-16. Estimated completion is 2026-03-31.
What conditions does trial NCT04995341 study?
This clinical trial studies the following conditions: Retinopathy of Prematurity.
What interventions are being tested in trial NCT04995341?
The interventions under investigation include: Investigational ultracompact OCT and OCTA system (DEVICE), retinal photographs (DEVICE).
Who is sponsoring clinical trial NCT04995341?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04995341 being conducted?
This trial has 2 study locations across North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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