INSULIN HUMAN for Intestinal malabsorption

Inclusion criteria

• {"criterion_text":"- Male or female preterm infants born at a gestational age below 26 weeks GA (<26+0) or 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. If both exist and differencediffer from each other > 2 weeks, determination will be based on early antenatal ultrasound\n- In the Investigator’s opinion, the infant is sufficiently stable to partake in the trial to completion\n- (France only) – only participants benefiting from a health insurance plan can participate in research.\n- Birth weight ≥ 450g\n- Singleton or twin birth\n- Postnatal age up through and including Day 5 (up to 120 hours post birth)\n- Fraction of inspired oxygen ≤ 0.60 at enrolment\n- Infant is cardiovascularly stable at time of enrolment and would be considered unstable if they require inotropic support\n- Infant is able to tolerate enteral feeds (defined as minimum of 10 ml/kg/day)\n- Infant is expected to wean off parenteral nutrition (PN) at the primary hospital\n- Informed consent form signed by parent(s) or legal guardian** ** One or both parents/ legal guardians as required by local regulations"}

Exclusion criteria

• {"criterion_text":"- Infant is consuming more than 80 ml/kg /day enterally at study entry\n- Any systemic insulin administration at randomization\n- Nothing per os (NPO) at study entry and enteral/oral supplements are not allowed\n- Subjects at risk for significant GI complications such as twin-to-twin transfusion syndrome (TTTS) or monochorionic monoamniotic twins\n- Participation in another interventional clinical study that may interfere with the results of this trial* * Participation in another interventional clinical study that may interfere with the results of this trial is not allowed until discharge from the primary hospital\n- Hypersensitivity to any of the drug components- Recombinant Human Insulin (rh-Insulin), Maltodextrin, Sodium Chloride\n- Infant is receiving pharmacological treatment for a hemodynamically significant PDA at the time of randomization\n- Heart and chest compression or any resuscitation drugs given to the infant during delivery\n- Infant is not dependent on any parenteral amino acids/lipids as nutrition\n- Major congenital malformation (e.g., infants with genetic, metabolic, and/or endocrine disorder diagnosed before enrolment)\n- For infants born under 26 weeks GA, IUGR is defined as weight for gestational age less than the third percentile according to Fenton preterm growth chart (see Appendix D)\n- Confirmed NEC\n- Maternal diabetes (Type I/II or gestational) requiring insulin during pregnancy or in mothers past medical history\n- a. Confirmed hyperinsulinemia OR b. Suspected hyperinsulinemia requiring glucose administration of more than 12 mg/kg/min at randomization.**.** When calculating the glucose infusion rate include all intravenous glucose sources (i.e. parenteral nutrition and glucose/ dextrose infusions)."}

Primary endpoints

• {"endpoint_text":"-\tAdverse Events (AEs) and Adverse Drug Reactions (ADRs)","definition_or_measurement_approach":""}
• {"endpoint_text":"-\tBlood glucose","definition_or_measurement_approach":""}
• {"endpoint_text":"-\tBlood Chemistry and haematology","definition_or_measurement_approach":""}
• {"endpoint_text":"-\tVital signs","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- The number of days to achieve full enteral feeding, defined as the number of days from treatment initiation to achieve enteral feeding* of at least 150 ml/kg/day for three consecutive days during the treatment period. *Defined as first day of reaching three consecutive days of EN feeds ≥150 ml/kg/day.","definition_or_measurement_approach":"Defined as first day of reaching three consecutive days of EN feeds ≥150 ml/kg/day."}
• {"endpoint_text":"- The number of days from treatment initiation to PN wean-off during the treatment period.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Incidence of severe NEC (modified Bell’s stage ≥2a) by 40 weeks post-menstrual age (PMA) or discharge home, whichever is earlier, according to modified Bell’s staging as assessed by central blinded reviewers and classified according to the “Modified Bell’s Staging Criteria for NEC” (Walsh-1986).","definition_or_measurement_approach":"Assessed by central blinded reviewers and classified according to the Modified Bell’s Staging Criteria for NEC (Walsh 1986)."}
• {"endpoint_text":"- Distribution of severity of NEC by 40 weeks PMA or discharge home, whichever is earlier, according to modified Bell’s staging as assessed by central blinded reviewers and classified according to the “Modified Bell’s Staging Criteria for NEC” (Walsh MC 1986).","definition_or_measurement_approach":"Assessed by central blinded reviewers and classified according to the Modified Bell’s Staging Criteria for NEC (Walsh MC 1986)."}
• {"endpoint_text":"- The number of days from treatment initiation to the first day the infant achieves EN volume of 120 ml/kg/day for three consecutive days during the treatment period.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Percentage of infants reaching FEF for three consecutive days within 9, 12, and 16 days from treatment initiation.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Percentage of infants weaned off PN within 7, 10, and 14 days from initiation of treatment.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Percentage of EN and PN over total nutrition during the treatment period.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Incidence of late onset sepsis (onset ≥72 hours after birth) by 40 weeks PMA or discharge home, whichever is earlier. Will be defined* as either: a)\tculture proven late onset sepsis OR b)\tclinically suspected culture negative late onset sepsis * According to EMA Report EMA/477725/2010 on the Expert Meeting on Neonatal and Paediatric Sepsis (8 June 2010)","definition_or_measurement_approach":"Defined as culture-proven late onset sepsis OR clinically suspected culture negative late onset sepsis according to EMA Report EMA/477725/2010."}
• {"endpoint_text":"- Neonatal anthropometrics measurements during the treatment period and up to 3 months CA.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Incidence of at least one of the adverse events of relevance by 40 weeks PMA or discharge home, whichever is earlier: •\tsevere NEC (modified Bell’s stage ≥2a); •\tlate onset sepsis; death","definition_or_measurement_approach":""}
• {"endpoint_text":"- The number of days from treatment initiation to discharge to home.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Incidence and severity of ROP up to 3 months CA according to the International Classification of Retinopathy of Prematurity (ICROP3)","definition_or_measurement_approach":"Classified according to the International Classification of Retinopathy of Prematurity (ICROP3)."}
• {"endpoint_text":"- The number of days from treatment initiation to discharge from primary hospital.","definition_or_measurement_approach":""}

Netherlands

Earliest CTIS Part Ii Submission Date

17-10-2024

Latest Decision Or Authorization Date

17-06-2025

Processing Time Days

243

Number Of Sites

3

Number Of Participants

15

France

Earliest CTIS Part Ii Submission Date

17-10-2024

Latest Decision Or Authorization Date

18-06-2025

Processing Time Days

244

Number Of Sites

5

Number Of Participants

5

Spain

Earliest CTIS Part Ii Submission Date

17-10-2024

Latest Decision Or Authorization Date

31-07-2025

Processing Time Days

287

Number Of Sites

7

Number Of Participants

15

Austria

Earliest CTIS Part Ii Submission Date

17-10-2024

Latest Decision Or Authorization Date

04-08-2025

Processing Time Days

291

Number Of Sites

1

Number Of Participants

10

Italy

Earliest CTIS Part Ii Submission Date

17-07-2025

Latest Decision Or Authorization Date

22-10-2025

Processing Time Days

97

Number Of Sites

1

Number Of Participants

10

Sweden

Earliest CTIS Part Ii Submission Date

27-03-2026

Latest Decision Or Authorization Date

09-04-2026

Processing Time Days

13

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Elgan Pharma Ltd.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Israel

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

sponsorDuties codes: 10, 6

Name

Premier Research Group Limited

Responsibilities

sponsorDuties codes: 1,10,11,12,2,3,5,6,7,8

Third parties

• {"country":"Israel","full_name":"Bioforum C.D.M.C Ltd.","duties_or_roles":"Unblinded Statistics for DMC meetings","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: 10, 6","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Germany","full_name":"PCI Pharma Services Germany GmbH","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties code: 15; value: Central imaging","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"sponsorDuties code: 15; value: Patient reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Italy","full_name":"Lb Research S.r.l.","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Servicio De Asesoria A La Investigacion Y Logistica S.L.","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Premier Research Group Limited","duties_or_roles":"sponsorDuties codes: 1,10,11,12,2,3,5,6,7,8","organisation_type":"Pharmaceutical company"}