Study to Evaluate Safety of ELGN-2112 Compared to Placebo in Preterm and Growth-Restricted Infants Born Before 32 Weeks

What this Trial Is About

Researchers are evaluating the safety of ELGN-2112 compared to a placebo in preterm infants born before 26 weeks of gestational age and in infants with intra-uterine growth restriction IUGR born between 26 and 32 weeks of gestational age. This phase 2 study aims to understand how ELGN-2112, a drug treatment, impacts these vulnerable infant groups in terms of safety. Participants will be randomly assigned to receive either ELGN-2112 or a placebo that contains the same inactive ingredients but no active drug. The study is double-blind, meaning neither the participants caregivers nor the researchers know who is receiving the drug or placebo. Treatment and monitoring will occur from five days after birth until 42 days. The study includes two groups preterm infants born less than 26 weeks GA and IUGR infants born between 26 and 32 weeks GA with very low birth weight. During the study, infants will be closely observed for safety outcomes over the 42-day treatment period. Researchers will measure and compare the safety of ELGN-2112 against placebo in these infant groups. The study lasts from shortly after birth through this 42-day period, with careful monitoring to track any effects of the treatment. Participants must be preterm infants fitting the specified gestational ages and birth weights to join the study.

Assess the Safety of ELGN-2112 in Preterm Infants Born Under 26 Weeks GA and IUGR Infants Born 26-32 Weeks GA