Analyzing Retinal Microanatomy in Retinopathy of Prematurity to Improve Care 2 and School Age Follow on Study (BabySTEPS2)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

• 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)

Locations
United States
North Carolina
Duke University Eye Center
RECRUITING
Durham
Pennsylvania
University of Pennsylvania, Center for Preventive Ophthalmology and Biostatistics
NOT_YET_RECRUITING
Philadelphia
Contact Information
Primary
Cynthia A Toth, MD
cynthia.toth@duke.edu
919-684-5631
Backup
Michelle N McCall, MCAPM, BA
michelle.mccall@duke.edu
919-684-0544
Time Frame
Start Date: 2021-08-16
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 236
Treatments
Experimental: Cohort 1: Functional and structural outcomes in children after bedside OCT imaging in infancy
109 pediatric participants who were previously enrolled in BabySTEPS1 from July 22, 2016 - December 30, 2020 will be enrolled for follow-up neurodevelopmental testing, visual acuity, visual function testing and investigational retinal imaging
Experimental: Cohort 2: Test of bedside OCT imaging data to predict RW-ROP or ROP progression
294 infants at risk for retinopathy of prematurity: 176 will be enrolled and have investigational bedside OCT retinal imaging, and their data will be combined with that from 118 infants who had similar imaging in BabySTEPS1 for analysis of the total group versus the indirect ophthalmoscopic clinical exam data.
Experimental: Cohort 3: Comparison of ROP imaging with investigational OCT versus retinal camera
102 infants, who are a sub-group of the 132 enrolled in Cohort 2, will also have imaging with a conventional, commercially available, retinal camera system to compare utility, stress, and prediction and documentation of referral-warranted ROP between the camera images and those from investigational OCT.
Experimental: Cohort 4: Adult and pediatric participants enrolled for imaging during system development
12 awake healthy adult controls and 6 pediatric participants undergoing examination under anesthesia in the operating room will be imaged with the investigational bedside OCT for the purpose of technological development.
Sponsors
Leads: Duke University
Collaborators: National Eye Institute (NEI), University of Pennsylvania

This content was sourced from clinicaltrials.gov