Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2) (NCT04995341) | Clinical Trial Compass
RecruitingNot Applicable
Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)
United States236 participantsStarted 2021-08-16
Plain-language summary
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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Optotype Visual acuity scores (Cohort 1 only)
Timeframe: 5-year study visit
2
Visual function scores (Cohort 1 only)
Timeframe: 4.75-year study visit
3
Neurodevelopmental scores at 2-year study visit (Cohort 1 only)
Timeframe: 2-year study visit
4
Retinal thickness at the fovea and surrounding optic nerve as measured by OCT reading (Cohort 1-3)
Timeframe: Up to 42 weeks post-menstrual age
5
Microanatomy as measured by OCT reading
Timeframe: Up to 42 weeks post-menstrual age
6
Microanatomy as measured by retinal photo reading (Cohort 3 only)
Timeframe: Up 42 weeks post-menstrual age
7
Microanatomy as measured by clinical exam (Cohort 1-3)