Effect of ELGN-2112 on intestinal malabsorption in preterm infants
A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants
This study is testing a new treatment called ELGN-2112 to see if it can help preterm infants better absorb nutrients from their food.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 1 Day to 5 Days |
| Sex | All |
| Sponsor | Elgan Pharma Ltd. Industry-sponsored |
| Locations | 1 site (Netanya) |
| Trial ID | NCT05670951 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of ELGN-2112 in treating intestinal malabsorption in preterm infants. The study involves administering ELGN-2112 to eligible participants and comparing the outcomes with a placebo group. It aims to determine whether this intervention can improve nutrient absorption in infants born between 26 and 32 weeks of gestation. The trial is designed to gather data on both the effectiveness and safety of the treatment in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born between 26 and 32 weeks of gestation with a birth weight of at least 500 grams.
Not a fit: Patients who are not preterm infants or those with gestational ages outside the specified range may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve nutrient absorption and overall health outcomes for preterm infants suffering from intestinal malabsorption.
How similar studies have performed: There is limited information on similar studies, making this approach relatively novel in the context of treating intestinal malabsorption in preterm infants.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female pre-term infant 26 and up to 32 weeks gestation. Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound * Birth weight ≥ 500g * Singleton or twin birth Exclusion Criteria: \-
Where this trial is running
Netanya
- Laniado Hospital — Netanya, Israel (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.