Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)

Launched by DUKE UNIVERSITY · Aug 5, 2021

Keywords

ClinConnect Summary

The BabySTEPS2 trial is studying a condition called Retinopathy of Prematurity (ROP), which can affect the vision of premature babies. This research aims to use a new imaging technology called high-speed optical coherence tomography (OCT) to see details in the eyes of very premature infants that traditional photographs might miss. By identifying early signs of ROP or other potential vision problems, doctors hope to provide better care and interventions that could improve a child's vision and overall development as they grow.

Parents and legal guardians of infants who were part of an earlier study (BabySTEPS1) may be eligible to participate in this trial. To join, they need to be willing to consent to the study and have their child examined around the age of 4.5 to 5 years. Participants will undergo eye examinations, and their health and development will be closely monitored. This trial is important because it seeks to improve how we can detect and treat vision issues in premature babies, leading to better outcomes for their future health and development.

Gender

ALL

Eligibility 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)