Assessing retinal health in preterm infants with advanced imaging techniques
Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care 2 and School Age Follow on Study (BabySTEPS2)
This study is testing a new imaging technique to see if it can better spot eye problems in very preterm infants at risk for vision issues compared to regular photos.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 236 (estimated) |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 2 sites (Durham, North Carolina and 1 other locations) |
| Trial ID | NCT04995341 on ClinicalTrials.gov |
What this trial studies
This study evaluates the use of high-speed optical coherence tomography (OCT) technology to identify retinal abnormalities in very preterm infants at risk for retinopathy of prematurity (ROP). By comparing this advanced imaging method to traditional bedside retinal photographs, the research aims to uncover critical indicators of ROP and potential future visual or neurological issues. The goal is to enhance early intervention strategies and improve long-term health outcomes for these vulnerable infants. The study will involve infants who have previously participated in a related study and will be followed up as they reach preschool age.
Who should consider this trial
Good fit: Ideal candidates include preterm infants born at Duke Hospital with a birth weight of ≤1000 grams or those at high risk for ROP treatment.
Not a fit: Patients who are not part of the specified cohorts or who do not have a clinically-indicated examination under anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and intervention for vision and neurodevelopmental issues in preterm infants.
How similar studies have performed: Other studies utilizing advanced imaging techniques for ROP have shown promise, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children previously enrolled in BabySTEPS1 (Pro00069721) that have already consented to being contacted for this school age follow on study, Cohort 1 only * Parent/Legal Guardian is able and willing to consent to study participation with follow up approximately between 4.5 and 5 years of age (consent available in Spanish\* and English) (SA 1 only) * Parent/Legal Guardian is able and willing to consent to study participation for the infant (SA 2 and 2c only) * Infant/child undergoing clinically-indicated examination under anesthesia that may or may not have eye pathology (SA 2 only) * Infant inborn or outborn at (SA 2 only): * Duke Hospital (Years 1, 2 and 3) with birth weight ≤1000 grams, and/or 20 0/7 to 28/ 6/7 (\<29 weeks) gestational age * Duke Hospital (Years 1, 2 and 3) at high risk to require treatment for ROP irrespective of birth weight and gestational age (e.g. pre-plus, severe ROP in zone 1, APROP, etc.) * Duke Regional Hospital (Years 4 and 5) that meets the American Association of Pediatrics eligibility of ROP screening (Infants with a birth weight of ≤1500 g or gestational age of 30 weeks) * Adults (over the age of 18 years) that may or may not have eye pathology (SA 2 only) Exclusion Criteria: * Participant or Parent/Legal Guardian unwilling or unable to provide consent * Adult participant or infant/child has a health or eye condition that preclude eye examination or retinal imaging (e.g. corneal opacity such as with Peter's anomaly or cataract) (SA2 only) * Infant has a health condition, other than prematurity, that has a profound impact on brain development (e.g. anencephaly) (SA2 only)
Where this trial is running
Durham, North Carolina and 1 other locations
- Duke University Eye Center — Durham, North Carolina, United States (Recruiting)
- University of Pennsylvania, Center for Preventive Ophthalmology and Biostatistics — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Cynthia A Toth, MD — Duke University Eye Center
- Study coordinator: Cynthia A Toth, MD
- Email: cynthia.toth@duke.edu
- Phone: 919-684-5631
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.