Prematurity - preterm birth feeding intolerance intestinal malabsorption in preterm infants
Conditions
Interventions
Following screening procedures eligible infants will be randomly assigned to
one of the two groups in a 1:1 ratio. Randomization should take place as close
as possible to treatment initiation and wi
Sponsors
ELGAN Pharma
Eligibility
Inclusion criteria
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
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. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of ELGN-2112 as compared to placebo in preterm infants born under 26 weeks GA and IUGR infants born between 26-32 weeks GA. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number 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. 2. Incidence of Necrotizing Enterocolitis (NEC) (Incidence of modified Bell*s stage grade >=2a of NEC) 3. Number of days until wean off PN (total cessation) 4. Distribution of severity of NEC according to modified Bell*s staging 5. Number of days to 120 ml/kg/day for three consecutive days 6. Percentage of infants reaching full enteral feeding at time points of interest from initiation of treatment. 7. Percentage of infants weaned off PN at time points of interest from initiation of treatment 8. Percent enteral/ parenteral feedings from total nutrition over time 9. Percentage of infants with sepsis 10. Percentage of subjects experiencing one of the adverse events of relevance (NEC, Infections, Death) 11. Number of days to discharge from primary hospital. 12. Number of days to discharge home. 13. Anthropometrics 14. Retinopathy of prematurity (ROP) activity score at 30-36 weeks PMA | — |
Countries
Netherlands
Outcome results
None listed