Clinical and Genetic Analysis of Retinopathy of Prematurity

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Maximum Age: 1
Healthy Volunteers: t
View:

• 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).

Locations
United States
California
Stanford University
NOT_YET_RECRUITING
Palo Alto
Illinois
University of Illinois Chicago
RECRUITING
Chicago
Michigan
William Beaumont Hospital
RECRUITING
Royal Oak
Oregon
Oregon Health & Science University
RECRUITING
Portland
Utah
University of Utah
NOT_YET_RECRUITING
Salt Lake City
Contact Information
Primary
John P Campbell, M.D.
campbelp@ohsu.edu
503-494-7891
Backup
Susan R Ostmo, M.S.
ostmo@ohsu.edu
503-494-7450
Time Frame
Start Date: 2011-07-01
Estimated Completion Date: 2030-05-31
Participants
Target number of participants: 2000
Treatments
i-ROP cohort
Premature infants who are at risk of retinopathy of prematurity(ROP) at participating study sites. As standard of care, babies who are born less than 31 weeks gestational age or less than 1500 grams are routinely screened for ROP. Families are approached to participate in this study where finding from babies' eye exams and associated retinal images along with demographic and other health data are collected and coded with unique identifier. No intervention is administered. The ROP exams and images obtained are done as a standard of care and would be performed even if there is no consent provided.
Related Therapeutic Areas
Sponsors
Collaborators: William Beaumont Hospitals, Stanford University, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Massachusetts General Hospital, University of Utah, U.S. National Science Foundation, National Institutes of Health (NIH), Northeastern University, National Eye Institute (NEI), University of Illinois at Chicago
Leads: Oregon Health and Science University

This content was sourced from clinicaltrials.gov