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A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Safety of ELGN-2112 in Populations of Interest
EU CTIS ID: 2024-517102-29-00
What this study is testing
To compare the safety of ELGN-2112 to placebo in preterm infants born less than 26 weeks GA and IUGR infants<3rd percentile born at 26-31+6 weeks GA up to 3 months CA (Part A). According to Fenton preterm growth chart
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female preterm infants born at a gestational age below 26 weeks GA (<26+0) or IUGR infants (below 3rd percentile), born between 26+0 to 31+6 GA*. * Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound. If both exist and differencediffer from each other > 2 weeks, determination will be based on early antenatal ultrasound
- In the Investigator’s opinion, the infant is sufficiently stable to partake in the trial to completion
- (France only) – only participants benefiting from a health insurance plan can participate in research.
- Birth weight ≥ 450g
- Singleton or twin birth
- Postnatal age up through and including Day 5 (up to 120 hours post birth)
You likely can't join if
- Infant is consuming more than 80 ml/kg /day enterally at study entry
- Any systemic insulin administration at randomization
- Nothing per os (NPO) at study entry and enteral/oral supplements are not allowed
- Subjects at risk for significant GI complications such as twin-to-twin transfusion syndrome (TTTS) or monochorionic monoamniotic twins
- Participation in another interventional clinical study that may interfere with the results of this trial* * Participation in another interventional clinical study that may interfere with the results of this trial is not allowed until discharge from the primary hospital
- Hypersensitivity to any of the drug components- Recombinant Human Insulin (rh-Insulin), Maltodextrin, Sodium Chloride
See the full eligibility criteria
- Male or female preterm infants born at a gestational age below 26 weeks GA (<26+0) or IUGR infants (below 3rd percentile), born between 26+0 to 31+6 GA*. * Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound. If both exist and differencediffer from each other > 2 weeks, determination will be based on early antenatal ultrasound
- In the Investigator’s opinion, the infant is sufficiently stable to partake in the trial to completion
- (France only) – only participants benefiting from a health insurance plan can participate in research.
- Birth weight ≥ 450g
- Singleton or twin birth
- Postnatal age up through and including Day 5 (up to 120 hours post birth)
- Fraction of inspired oxygen ≤ 0.60 at enrolment
- Infant is cardiovascularly stable at time of enrolment and would be considered unstable if they require inotropic support
- Infant is able to tolerate enteral feeds (defined as minimum of 10 ml/kg/day)
- Infant is expected to wean off parenteral nutrition (PN) at the primary hospital
- Informed consent form signed by parent(s) or legal guardian** ** One or both parents/ legal guardians as required by local regulations
- Infant is consuming more than 80 ml/kg /day enterally at study entry
- Any systemic insulin administration at randomization
- Nothing per os (NPO) at study entry and enteral/oral supplements are not allowed
- Subjects at risk for significant GI complications such as twin-to-twin transfusion syndrome (TTTS) or monochorionic monoamniotic twins
- Participation in another interventional clinical study that may interfere with the results of this trial* * Participation in another interventional clinical study that may interfere with the results of this trial is not allowed until discharge from the primary hospital
- Hypersensitivity to any of the drug components- Recombinant Human Insulin (rh-Insulin), Maltodextrin, Sodium Chloride
- Infant is receiving pharmacological treatment for a hemodynamically significant PDA at the time of randomization
- Heart and chest compression or any resuscitation drugs given to the infant during delivery
- Infant is not dependent on any parenteral amino acids/lipids as nutrition
- Major congenital malformation (e.g., infants with genetic, metabolic, and/or endocrine disorder diagnosed before enrolment)
- For infants born under 26 weeks GA, IUGR is defined as weight for gestational age less than the third percentile according to Fenton preterm growth chart (see Appendix D)
- Confirmed NEC
- Maternal diabetes (Type I/II or gestational) requiring insulin during pregnancy or in mothers past medical history
- a. Confirmed hyperinsulinemia OR b. Suspected hyperinsulinemia requiring glucose administration of more than 12 mg/kg/min at randomization.**.** When calculating the glucose infusion rate include all intravenous glucose sources (i.e. parenteral nutrition and glucose/ dextrose infusions).
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.