Actively Recruiting
Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)
Led by Duke University · Updated on 2025-10-06
236
Participants Needed
2
Research Sites
241 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
U
University of Pennsylvania
Collaborating Sponsor
AI-Summary
What this Trial Is About
Retinopathy of prematurity (ROP) is a disorder of development of the neural retina and its vasculature that can impact vision in vulnerable preterm neonates for a lifetime. This study tests high-speed optical coherence tomography (OCT) technology compared to conventional color photographs at the bedside of very preterm infants in the intensive care nursery, to characterize previously unseen abnormalities that can predict a need for referral for ROP treatment, or poor visual or neurological development later in life, up to pre-school age. Our long-term goal is to help improve preterm infant health and vision via objective bedside imaging and analysis that characterizes early critical indicators of ROP, and poor visual function and neurological development, which will rapidly translate to better early intervention and improved future care.
CONDITIONS
Official Title
Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children previously enrolled in BabySTEPS1 who consented to be contacted for this follow-on study (Cohort 1 only)
- Parent or legal guardian is able and willing to consent for study participation with follow-up around 4.5 to 5 years of age (SA 1 only)
- Parent or legal guardian is able and willing to consent for study participation for the infant (SA 2 and 2c only)
- Infant or child undergoing clinically-indicated eye examination under anesthesia (SA 2 only)
- Infant born at Duke Hospital (Years 1, 2, and 3) with birth weight 1000 grams or less and/or gestational age less than 29 weeks
- Infant born at Duke Hospital (Years 1, 2, and 3) at high risk for ROP treatment regardless of birth weight or gestational age
- Infant born at Duke Regional Hospital (Years 4 and 5) meeting American Academy of Pediatrics criteria for ROP screening (birth weight 1500 grams or less or gestational age 30 weeks or less)
- Adults over 18 years old who may or may not have eye pathology (SA 2 only)
You will not qualify if you...
- Participant or parent/legal guardian unwilling or unable to provide consent
- Adult or infant/child has a health or eye condition preventing eye examination or retinal imaging (e.g., corneal opacity or cataract) (SA 2 only)
- Infant has a health condition other than prematurity that severely affects brain development (e.g., anencephaly) (SA 2 only)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Duke University Eye Center
Durham, North Carolina, United States, 27705
Actively Recruiting
2
University of Pennsylvania, Center for Preventive Ophthalmology and Biostatistics
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
Research Team
C
Cynthia A Toth, MD
CONTACT
M
Michelle N McCall, MCAPM, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
4
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