Prematurity - preterm birth feeding intolerance intestinal malabsorption in preterm infants
Conditions
Interventions
The study will be comprised of 180 infants per arm, in two strata (26+0-28+6
&
29+0-32+0 GA) or at least 360 infants in all, with at least 140 (70 per
arm) in the younger strata. Each infant will be randomly assigned in a 1:1
ratio to the study medication (ELGN-2112) or placeb
Sponsors
ELGAN Pharma
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
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. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numbers of days to achieve full enteral feeding, defined as the first day of ability of the preterm infant to achieve enteral feeding of at least 150 ml/kg/day for three consecutive days. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of days until wean off PN 2. Incidence of Necrotizing Enterocolitis (NEC) (modified Bell*s stage grade >=2a) in infants born at 26-28 weeks GA. 3. Number of days to discharge from primary hospital 4. Distribution of severity of NEC according to modified Bell*s staging in infants born at 26-28 weeks GA. 5. Incidence of Necrotizing Enterocolitis (NEC) (modified Bell*s stage grade >=2a) in the entire study population. 6. Distribution of severity of NEC according to modified Bell*s staging in the entire study population. 7. Percentage of infants reaching full enteral feeding within 6, 8, and 10 days from initiation of treatment. 8. Number of days to 120 ml/kg/day for three consecutive days 9. Percentage of infants weaned off PN within 4, 6, and 8 days from initiation of treatment 10. Percent enteral/ parenteral feedings from total nutrition over time 11. Percentage of infants with sepsis 12. Percentage of subjects experiencing one of the adverse events of relevance (NEC, Infections, Death) 13. Number of days to discharge to home 14. Anthropometrics 15. Retinopathy of prematurity (ROP) activity score at 30-36 weeks PMA | — |
Countries
Netherlands
Outcome results
None listed