Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorDuke University

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Investigational ultracompact OCT and OCTA system
  • retinal photographs

Treatment groups

236 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Duke University

Lead sponsor

University of Pennsylvania

Collaborator

National Eye Institute (NEI)

Collaborator