RECRUITING

Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-08-16
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04995341

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Children previously enrolled in BabySTEPS1 (Pro00069721) that have already consented to being contacted for this school age follow on study, Cohort 1 only
  2. * 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)
  3. * Parent/Legal Guardian is able and willing to consent to study participation for the infant (SA 2 and 2c only)
  4. * Infant/child undergoing clinically-indicated examination under anesthesia that may or may not have eye pathology (SA 2 only)
  5. * Infant inborn or outborn at (SA 2 only):
  6. * 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
  7. * 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.)
  8. * 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)
  9. * Adults (over the age of 18 years) that may or may not have eye pathology (SA 2 only)
  1. * Participant or Parent/Legal Guardian unwilling or unable to provide consent
  2. * 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)
  3. * Infant has a health condition, other than prematurity, that has a profound impact on brain development (e.g. anencephaly) (SA2 only)

Contacts and Locations

Study Contact

Cynthia A Toth, MD
CONTACT
919-684-5631
cynthia.toth@duke.edu
Michelle N McCall, MCAPM, BA
CONTACT
919-684-0544
michelle.mccall@duke.edu

Principal Investigator

Cynthia A Toth, MD
PRINCIPAL_INVESTIGATOR
Duke University Eye Center

Study Locations (Sites)

Duke University Eye Center
Durham, North Carolina, 27705
United States
University of Pennsylvania, Center for Preventive Ophthalmology and Biostatistics
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Duke University

  • Cynthia A Toth, MD, PRINCIPAL_INVESTIGATOR, Duke University Eye Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-16
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2021-08-16
Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

  • Optical Coherence Tomography (OCT)
  • Optical Coherence Tomography Angiography (OCTA)
  • Retinopathy of Prematurity
  • Neurodevelopment
  • Visual Acuity

Additional Relevant MeSH Terms

  • Retinopathy of Prematurity