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
- Conditions
- Prematurity - preterm birthfeeding intoleranceintestinal malabsorption in preterm infants10025477
- Registration Number
- NL-OMON53803
- Lead Sponsor
- ELGAN Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 70
1. Male or female preterm infant 26 and up to 32 weeks gestation (32 weeks + 0
day maximum). Gestational age matching (±2 weeks) between maternal dates and/or
early antenatal ultrasound * 2. Birth weight >= 500 g 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
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. Intra-uterine growth restriction (IUGR) defined as either 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. Heart and chest compression or 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 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>Numbers of days to achieve full enteral feeding, defined as the first day of<br /><br>ability of the preterm infant to achieve enteral feeding of at least 150<br /><br>ml/kg/day for three consecutive days.</p><br>
- Secondary Outcome Measures
Name Time Method