PEDIATRICS
Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP), a Randomized, Controlled Trial, I: Primary Outcomes
The STOP-ROP Multicenter Study Group
Objective To determine the efficacy and safety of supplemental therapeutic oxygen for infants with prethreshold retinopathy of prematurity (ROP) to reduce the probability of progression to threshold ROP, and therefore the need for peripheral retinal ablation.
Methods: Premature infants with confirmed prethreshold ROP in at least 1 eye and median pulse oximetry less than 94% saturation were randomized to a Conventional oxygen arm with pulse oximetry targeted at 89% to 94% saturation, or a Supplemental arm with pulse oximetry targeted at 96% to 99% saturation, for at least 2 weeks, and until both eyes were at study endpoints. Certified examiners masked to treatment assignment conducted weekly eye examinations until each study eye reached ophthalmic endpoint. An adverse ophthalmic endpoint for an infant was defined as reaching threshold criteria . . . [Full Text of this Article]
