| NCT ID | NCT04420156 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oregon Health and Science University |
| Condition | Retinopathy of Prematurity |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2011-07-01 |
| Primary Completion | 2024-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2011-07-01 with a primary completion date of 2024-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
John P Campbell, M.D.
PRINCIPAL INVESTIGATOR
Oregon Health and Science University
Frequently Asked Questions
Who can join the NCT04420156 clinical trial?
This trial is open to participants of all sexes, up to 1 Year, studying Retinopathy of Prematurity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04420156 currently recruiting?
Yes, NCT04420156 is actively recruiting participants. Contact the research team at campbelp@ohsu.edu for enrollment information.
Where is the NCT04420156 trial being conducted?
This trial is being conducted at Palo Alto, United States, Chicago, United States, Royal Oak, United States, Portland, United States and 1 additional location.
Who is sponsoring the NCT04420156 clinical trial?
NCT04420156 is sponsored by Oregon Health and Science University. The principal investigator is John P Campbell, M.D. at Oregon Health and Science University. The trial plans to enroll 2,000 participants.