INS-3-08-b in INS-3: A Phase 3, Randomized, Double-Masked, Placebo-Controlled Study of the Efficacy and Safety of myo-Inositol 5% Injection to Increase Survival without Severe Retinopathy of Prematurity (Reduce-ROP) in Extremely Premature Infants

INS-3-08-b
Study Description
The objective of this study was to determine the efficacy and safety of myo-Inositol 5% Injection compared to placebo for increasing the probability of survival without severe Retinopathy of Prematurity in premature infants <28 weeks’ gestation followed through the determination of final/acute ROP
status or 55 weeks PMA. The trial was stopped early based on a statistically significant increase in all-cause deaths through 55 weeks’ PMA in the myo-inositol group. Infants enrolled in the trial were gestational age of less than 28 weeks (27 6/7 weeks and younger), alive at 12 hours and at age up to 72 hours of life.