FIT-PIV Study
Many premature babies have digestive systems that are still developing, which can make feeding difficult in the early weeks of life.
Insulin has been found to help the intestines grow and develop. It is normally found in breast milk and in the amniotic fluid. The purpose of this study is to learn if giving ELGN-2112 (insulin) can help the intestines work better, improve feeding tolerance, and help premature babies reach full milk feedings sooner.
Purpose & Aim
Population of the study: Preterm infants 26 0/7 to 31 6/7 weeks’ gestation
Intervention: ELGN-2112 (insulin) vs. placebo
Outcome: Number of days to full enteral feeding
Trial Information
Target Enrollment: 420
Funder: ELGAN Pharma Ltd.
Duration of Study: February 2025 – May 2029
Study Principal Investigator
Matthew Rysavy, MD, PhD
Associate Professor
Department of Pediatrics, Division of Neonatology
Institute for Clinical Research and Learning Healthcare
Director of Learning Healthcare
6431 Fannin, MSB 2.106
Houston, TX 77030
[email protected]
Links
Clinical Trials (external link)
Parent Brochure (external link)
Video (external link)