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
Study ID: STU 012014-069
This is a randomized, double-masked, placebo-controlled study designed to determine the effectiveness of myo-inositol 5% injection to increase survival without severe RoP among premature infants [Less Than]28 0/7 weeks gestation. infants will be randomized in a 1:1 allocation, stratified by center and by 2 gestational age (Ga) risk strata ([Less Than]26 and 26-27 weeks) to receive either myo-inositol 5% injection or placebo. assessments performed during the study include usual newborn intensive care procedures including repeat eye examinations until acute RoP status is final (which often extends after discharge) up to 55 weeks PMa, measurements of growth and the collection of clinical diagnoses throughout hospitalization to evaluate other common morbidities of extreme preterm birth. adverse events will be recorded from treatment initiation until 7 days after the last dose of study drug, and concurrent medications will be recorded from 24 hours prior to randomization until 7 days after the last dose of study drug, or until discharge or transfer if sooner. Longer-term data will be collected using the separate nRn Follow-up Program Protocol at 22-26 months corrected age, including growth, neurodevelopmental testing, overall health status, re-hospitalizations, surgeries and diagnoses including ophthalmologic diagnoses and treatments following discharge. The primary hypothesis will be tested based on a score test of the treatment effect in the Poisson regression model where the null hypothesis of no treatment effect on survival without severe RoP is rejected at either the interim or final analysis with a p-value consistent with an overall Type 1 error rate of 0.05 and a Bonferroni-type correction for multiple comparisons. For this analysis, individuals with indeterminate primary outcome status (i.e. alive through 55 weeks PMa and did not meet final acute RoP status but have RoP assessment data available), will go through an endpoint adjudication process and the resulting adjudicated endpoints will be used in the analyses. individuals with completely missing outcomes (i.e. no RoP follow-up or death information available) or for which an adjudicated endpoint cannot be determined will be excluded from the analyses.
1. <28 weeks gestational age 2. survival at least 12 hours 3. informed consent 4. enrollment < 72 hours of age