A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Basket Study to Assess the Safety of ELGN-2112 in Populations of Interest

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

1. Male or female preterm infant born less than 26 weeks GA (up to 25+6) or
Intra-Uterine Growth Restricted (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. 2. Birth weight >= 450g 3. Singleton or
twin birth 4. Postnatal age up through and including Day 5 (up to 120 hours
post birth) 5. Fraction of inspired oxygen <= 0.60 at enrolment 6. Infants must
demonstrate cardiovascular stability at time of enrolment and would be
considered unstable if they require blood pressure support via a central line
7. Infant is able to tolerate enteral feeds 8. Infant is expected to wean off
parenteral nutrition (PN) at the primary hospital 9. Informed consent form
signed by parents or legal guardian 10. In the Investigator*s opinion, the
infant is sufficiently stable to partake in the trial to completion * If both
exist and difference > 2 weeks, based on early antenatal ultrasound

Exclusion Criteria

1. Infant is consuming more than 100 ml/kg /day enterally at study entry
2. Infant is not dependent on any parenteral amino acids/lipids as nutrition
3. Major congenital malformation (e.g., infants with genetic, metabolic, and/or
endocrine disorder diagnosed before enrolment)
4. For infants born under 26 weeks GA, Intra-uterine growth restriction (IUGR)
defined as weight for gestational age less than the third percentile according
to Fenton preterm growth chart.
5. Confirmed necrotizing enterocolitis (NEC)
6. Maternal diabetes (Type I/II or gestational) requiring insulin during
pregnancy or in mothers past medical history.
7. Suspected or confirmed hyperinsulinemia requiring glucose administration of
more than 12 mg/kg/min at randomization.
8. Any systemic insulin administration at randomization.
9. Nothing per os (NPO) at study entry and enteral/oral supplements are not
allowed
10. Any resuscitation drugs given to the infant during delivery
11. Subjects at risk for significant GI complications such as twin-to-twin
transfusion syndrome (TTTS) or monochorionic monoamniotic twins.
12. Participation in another interventional clinical study that may interfere
with the results of this trial**
13. Hypersensitivity to any of the drug components- Recombinant Human Insulin
(rh-Insulin), Maltodextrin, Sodium Chloride
** Participation in another interventional clinical study that may interfere
with the results of this trial is not allowed until discharge from the hospital

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety of ELGN-2112 as compared to placebo in preterm infants born under 26<br /><br>weeks GA and IUGR infants born between 26-32 weeks GA.</p><br>

Secondary Outcome Measures