Actively Recruiting

Age: 0 - 1Year
All Genders
Healthy Volunteers
NCT04420156

Clinical and Genetic Analysis of ROP

Led by Oregon Health and Science University · Updated on 2022-04-20

2000

Participants Needed

5

Research Sites

987 weeks

Total Duration

On this page

Sponsors

O

Oregon Health and Science University

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Clinical and Genetic Analysis of ROP

Who Can Participate

Age: 0 - 1Year
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants hospitalized at participating Neonatal Intensive Care Units who meet published criteria for requiring ROP screening examination
  • Infants transferred to the study center for specialized ophthalmic care
  • Eligibility criteria match national guidelines jointly published by the American Academy of Pediatrics, American Academy of Ophthalmology, and American Association for Pediatric Ophthalmology and Strabismus
Not Eligible

You will not qualify if you...

  • Infants with structural ocular anomalies
  • Infants considered unstable for examination by their attending neonatologist

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Stanford University

Palo Alto, California, United States, 94303

Not Yet Recruiting

2

University of Illinois Chicago

Chicago, Illinois, United States, 60607

Actively Recruiting

3

William Beaumont Hospital

Royal Oak, Michigan, United States, 48073

Actively Recruiting

4

Oregon Health & Science University

Portland, Oregon, United States, 97239

Actively Recruiting

5

University of Utah

Salt Lake City, Utah, United States, 84132

Not Yet Recruiting

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Research Team

J

John P Campbell, M.D.

CONTACT

S

Susan R Ostmo, M.S.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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