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

Launched by ELGAN PHARMA LTD. · Jun 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ELGN-2112 to see how safe it is for very premature infants. Specifically, it focuses on babies born before 26 weeks of pregnancy and those who are smaller than expected for their age, known as intra-uterine growth restricted (IUGR) infants, who were born between 26 and 32 weeks. The trial will compare the safety of ELGN-2112 with a placebo, which is a treatment that looks like the real medicine but doesn’t contain any active ingredients.

To participate in the trial, infants need to be either a preterm baby born before 26 weeks or an IUGR baby born between 26 and 32 weeks. They should weigh at least 450 grams (about 1 pound) and can be a single baby or a twin. If families choose to take part, they will help researchers understand how safe this new treatment is for these vulnerable infants. It’s important to note that this trial is not yet recruiting participants, so it’s still in the planning phase.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female preterm infant born less than 26 weeks GA or Intra-Uterine Growth Restricted infants born between 26+0 to 31+6 GA.
• • Birth weight ≥ 450g
• • Singleton or twin birth
• Exclusion Criteria:
• • N/A