Recruiting NCT05670951
Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ELGN-2112, Placebo.
- Who it may be relevant to
- Registry conditions: Intestinal Malabsorption. Basic parameters: 1 Day — 5 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
The study will evaluate the effect of ELGN-2112 on intestinal malabsorption in preterm infants.
Interventions
- Drug ELGN-2112
Human insulin \[rDNA\] - Drug Placebo
Placebo
Primary outcome measures
- Numbers of days to achieve full enteral feeding [Time frame: 28 days or discharge from hospital]
Eligibility 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
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Israel · 1 center
- Laniado Hospital — Netanya
Identifiers
NCT: NCT05670951 · FIT-PIV