Gastro-intestinal malabsorption due to gastro-intestinal immaturity in preterm infants. MedDRA version: 20.1 Level: LLT Classification code 10025479 Term: Malabsorption syndrome System Organ Class: 100000004856
Conditions
Interventions
Product Name: ELGN-2112
Product Code: ELGN-2112
Pharmaceutical Form: Powder for oral solution
Pharmaceutical form of the placebo: Powder for oral solution
Route of administration of the placebo: Enter
Sponsors
Elgan Pharma Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female preterm infant born less than 26 weeks Gestational Age (up to 25+6) or Intra-Uterine Growth Restricted (IUGR) infants (below 3rd percentile), born between 26+0 to 31+6 Gestational Age. 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 11. (France only) – only participants benefiting from a health insurance plan can participate in research. Are the trial subjects under 18? yes Number of subjects for this age range: 60 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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 Gestational Age, 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. Subjects at risk for significant GI complications such as twin-to-twin transfusion syndrome (TTTS) or monochorionic monoamniotic twins. 11. Participation in another interventional clinical study that may interfere with the primary and secondary outcomes of this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the safety of treatment with ELGN-2112 to placebo in preterm infants born less than 26 weeks Gestational Age and Intra-uterine growth restriction infants <3rd percentile born at 26-32 weeks Gestational Age.;Secondary Objective: 1. To assess the efficacy of treatment with ELGN-2112 as compared to placebo on intestinal malabsorption in preterm infants as measured by the time to full enteral feeding (Defined as first day of reaching three consecutive days of enteral feeding =150 ml/kg/day) 2. To assess effect of ELGN-2112 compared to placebo on number of days until full wean off parenteral nutrition (total cessation) 3. To assess the effect of ELGN-2112 on Incidence and severity of Necrotizing Enterocolitis (NEC). a. Incidence of modified Bell’s stage grade =2a of NEC in the entire study population. b. Distribution of severity of NEC according to modified Bell’s staging in infants who experienced NEC in the entire study population. 4. To assess the effect of ELGN-2112 on Percent of infants with culture proven nosocomial sepsis 5. To assess the effect of ELGN-2112 on Percent of infants experiencing one of the adverse events of relevance (NEC, Infections, Death) ;Primary end point(s): Safety of ELGN-2112 as compared to placebo in preterm infants born under 26 weeks Gestational Age and Intra-uterine growth restriction infants born between 26-32 weeks Gestational Age.;Timepoint(s) of evaluation of this end point: Up to 42 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 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. Number of days until wean off parenteral nutrition (total cessation) 3. Incidence and severity of Necrotizing Enterocolitis (NEC) a. Incidence of modified Bell’s stage grade =2a of NEC in the entire study population. b. Distribution of severity of NEC according to modified Bell’s staging in infants who experienced NEC in the entire study population. 4. Number of events of culture proven nosocomial Sepsis 5. Percentage of subjects experiencing one of the adverse events of relevance (NEC, Infections, Death) 6. Number of days to 120 ml/kg/day for three consecutive days 7. Number of days until parenteral nutrition wean off (time to amino acids and lipids withdrawal) 8. Percent enteral/parenteral feedings from total nutrition over time 9. Number of days to discharge from primary hospital. 10. Number of days from randomization to discharge home. 11. Anthropometrics 12. Retinopathy of prematurity (ROP) activity score at 30-36 weeks PMA;Timepoint(s) of evaluation of this end point: Up to 3 months. | — |
Countries
Austria, France, Israel, Italy, Netherlands, Spain, Sweden, United States
Contacts
Public ContactClaire Pellet
Claire Pellet freelance consultant
Outcome results
None listed