Analyzing clinical and genetic factors in Retinopathy of Prematurity
Clinical and Genetic Analysis of Retinopathy of Prematurity
This study is trying to see if combining clinical and genetic information can help improve the care and diagnosis of Retinopathy of Prematurity in low birth weight infants using artificial intelligence.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | N/A to 1 Year |
| Sex | All |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 5 sites (Palo Alto, California and 4 other locations) |
| Trial ID | NCT04420156 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on Retinopathy of Prematurity (ROP), a condition affecting the retinas of low birth weight infants. It aims to combine clinical and genetic data to enhance understanding and management of ROP through artificial intelligence and analytics. Participants will be recruited from neonatal intensive care units across five collaborating institutions, where they will undergo routine ROP screening and have retinal images collected for analysis. The study seeks to develop a quantitative framework for ROP care and evaluate the accuracy of AI systems in diagnosing and screening this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are hospitalized infants in NICUs who require ROP screening examinations.
Not a fit: Patients with structural ocular anomalies or those deemed unstable for examination by their neonatologist may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and management of Retinopathy of Prematurity, potentially reducing childhood blindness.
How similar studies have performed: Other studies have shown promise in using AI for medical diagnostics, suggesting potential success for this approach in ROP.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All infants hospitalized at participating Neonatal Intensive Care Units will be eligible for the study if they meet plublished criteria for requiring ROP screening examination, or if they are transferred to the study center for specialized ophthalmic care. These eligibility criteria are identical at each study center, and match what is done in standard clinical practice according to national guidelines published jointly by the American Academy of Pediatrics, American Academy of Ophthalmology, and American Associatioin for Pediatric Ophthalmology and Strabismus (AAP-AAO, Pediatrics, 2013). Exclusion Criteria: * Patients will be excluded if they have structural ocular anomalies, or if they are considered unstable for examintion by their attending neonatologist.
Where this trial is running
Palo Alto, California and 4 other locations
- Stanford University — Palo Alto, California, United States (Not_yet_recruiting)
- University of Illinois Chicago — Chicago, Illinois, United States (Recruiting)
- William Beaumont Hospital — Royal Oak, Michigan, United States (Recruiting)
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
- University of Utah — Salt Lake City, Utah, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: John P Campbell, M.D. — Oregon Health and Science University
- Study coordinator: John P Campbell, M.D.
- Email: campbelp@ohsu.edu
- Phone: 503-494-7891
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.