Clinical and Genetic Analysis of ROP (NCT04420156)
Clinical and Genetic Analysis of Retinopathy of Prematurity
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Stanford University — Palo Alto, California
Age range: Not specified to 1 Year
🧪 Interventions in This Study
- No intervention administered. (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (5 Sites)
- Stanford University — Palo Alto, California
- University of Illinois Chicago — Chicago, Illinois
- William Beaumont Hospital — Royal Oak, Michigan
- Oregon Health & Science University — Portland, Oregon
- University of Utah — Salt Lake City, Utah
📞 Contact the Study Coordinator
Phone: (503) 494-7891
Email: campbelp@ohsu.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Retinopathy of Prematurity
- Bevacizumab Treatment For Type 1 ROP — Little Rock, Arkansas
- Validation of i-ROP DL to Detect More Than Mild ROP — Portland, Oregon
- Extension Study to Evaluate the Long-Term Outcomes of Pediatric Patients Who Received Treatment for Retinopathy of Prematurity in the VGFTe-ROP-1920 Study (Acronym: Butterfleye Next) — La Jolla, California
- Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2) — Durham, North Carolina
- Imaging Retinal Vasculature in Infant Eyes — Durham, North Carolina
Explore by condition: All Retinopathy of Prematurity clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.