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NCT04420156 · ClinicalTrials.gov registry record

Clinical and Genetic Analysis of ROP

A clinical trial of Retinopathy of Prematurity, sponsored by Oregon Health and Science University.

Recruiting
Registry status
2,000
Enrollment target
5
Study locations

NCT04420156: Recruiting study of Retinopathy of Prematurity, sponsored by Oregon Health and Science University.

NCT04420156 is a study of Retinopathy of Prematurity that is actively recruiting participants, run by Oregon Health and Science University. The registered enrollment target is 2,000 participants, above the 83-participant average among 7 other Retinopathy of Prematurity trials with a reported enrollment target (2310% higher). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04420156, a study of Retinopathy of Prematurity, is actively recruiting participants, sponsored by Oregon Health and Science University.

RECRUITING
Registry status
2,000 participants
Enrollment target
5
Study locations

Study Summary

Retinopathy of Prematurity (ROP) is a vascular disease affecting the retinas (back of the eye) of low birth weight infants. Although it can be treated effectively if diagnosed early, it continues to be a leading cause of childhood blindness in the United States and throughout the world. The investigators feel that this study will result in specific knowledge discovery about ROP, as well as general knowledge about how image-based data and genetic data can be combined to better understand clinical disease. Participants will be recruited from the neonatal intensive care unit (NICU) at OHSU, along with 4 collaborating institutions (William Beaumont Hospital, Stanford University, University of Illinois Chicago and University of Utah). Hospitalized infants who receive ROP screening examinations for routine care will be eligible for this study, and will be offered the opportunity to participate. Subjects who provide informed consent will have clinical data from routine care collected along with demographic characteristics, results from routine ROP screening examinations, presence of systemic disease or risk factors. Retinal photographs will be taken during these routine eye exams, using a commercially-available camera that has been FDA-cleared for taking pictures from retinas of premature infants. These retinal pictures do not contain any identifiable patient information, and are taken as routine standard of care. The long-term goal of this research is to establish a quantitative framework for retinopathy of prematurity (ROP) care based on clinical, imaging, genetic, and informatics principles. The investigators have previously recruited and rigorously phenotyped and genotyped a large study cohort, including implementation of a novel reference standard diagnosis; and built a world-class research consortium for image, genetic, and bioinformatics analysis.

Primary Outcome

Premature babies are examined for retinopathy of prematurity (ROP), a potentially blinding diesese. As a standard of care, retinal images are taken during ROP examinations. This research group has collected a repository of images over the past 9 years and with those images, the investigators have developed an artificial intelligence (AI) system that has the ability to diagnose severe ROP with high accuracy. The primary outcome measure in continuing to recruit subjects for this study is to collec

Conditions Studied

Interventions

  • OTHER No intervention administered.

Study Locations (5)

California

  • Stanford University - Palo Alto

Illinois

  • University of Illinois Chicago - Chicago

Michigan

  • William Beaumont Hospital - Royal Oak

Oregon

  • Oregon Health & Science University - Portland

Utah

  • University of Utah - Salt Lake City

Trial Details

FieldValue
Enrollment Target 2,000 participants
Start Date 2011-07-01
Est. Completion 2030-05-31

What NCT04420156 shows while recruiting

NCT04420156 is an observational study that tracks outcomes without assigning an intervention. Its 2,000 participants enrollment target places it among the larger protocols in the corpus, above the 83-participant average among 7 other Retinopathy of Prematurity trials with a reported enrollment target (2310% higher).

The record links to 1 condition, with Retinopathy of Prematurity appearing as the primary indexed condition, and to 1 intervention - of which No intervention administered. is the first listed.

NCT04420156 lists 5 locations in 5 states (California, Illinois, Michigan).

Frequently Asked Questions

What is clinical trial NCT04420156 about?

NCT04420156 is a clinical study titled "Clinical and Genetic Analysis of ROP". Retinopathy of Prematurity (ROP) is a vascular disease affecting the retinas (back of the eye) of low birth weight infants. Although it can be treated effectively if diagnosed early, it continues to be a leading cause of childhood blindness in the United States and throughout the world. The investig...

What is the current status of trial NCT04420156?

This trial is currently recruiting. The enrollment target is 2,000 participants. The study started on 2011-07-01. Estimated completion is 2030-05-31.

What conditions does trial NCT04420156 study?

This clinical trial studies the following conditions: Retinopathy of Prematurity.

What interventions are being tested in trial NCT04420156?

The interventions under investigation include: No intervention administered. (OTHER).

Who is sponsoring clinical trial NCT04420156?

This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04420156 being conducted?

This trial has 5 study locations across California, Illinois, Michigan, Oregon, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT04420156, the US trial registry maintained by the National Library of Medicine. NCT04420156 (large enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.