Study on the prevention of necrotizing enterocolitis (a severe inflammation and death go intestines) in premature infants

A randomized, double blind, parallel-group, placebo controlled study to evaluate the efficacy and safety of IBP-9414 in premature infants 500-1500g birth weight in the prevention of necrotizing enterocolitis – The Connection study - The Connection study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000754-22-HU

Enrollment

2158

Registered

2019-04-09

Start date

2019-06-14

Completion date

Unknown

Last updated

2024-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotizing Enterocolitis (NEC) MedDRA version: 20.1 Level: LLT Classification code 10052818 Term: Necrotizing enterocolitis neonatal System Organ Class: 100000004856

Interventions

Product Name: IBP-9414 Product Code: IBP-9414 Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: not available CAS Number: not availabl Current Sponsor code: IBP-9414 Other descri

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Gestational age at birth of 23 weeks + 0 days -32 weeks + 0 days 2. Birth weight 500-1500g. (First infants with birth weights 750-1000g will be included. After a DMC recommendation, infants with birth weights 500-1000g will then be included. After 1400 subjects in the study, infants with birth weights 500-1500g will then be included.) 3. = 48 hours of age 4. Written informed consent from the subject´s legally authorized representative (LAR) Are the trial subjects under 18? yes Number of subjects for this age range: 2158 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. Participation in any other interventional clinical trial 2. Infants in extremis to whom no further intensive care is offered by attending neonatologist (e.g., infant being provided only hospice/comfort care) 3. Infants with, or at a high probability for, early onset sepsis (positive blood cultures or with clinical/histological chorioamnionitis (according to Higgins et al, 2016), and with the expectation of empirical antimicrobial therapy for > five days) 4. Infants with recognized chromosomal anomalies 5. Congenital or acquired gastrointestinal disease 6. Earlier or planned administration of formulas, foods or supplements that contain added live bacteria, including all infant formulas or food supplement products with added so-called ”probiotic” or added live bacterial content during the study 7. Infants with known positive maternal HIV status

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of IBP-9414 vs. placebo on the prevention of necrotizing enterocolitis and on sustained feeding tolerance in very low birth weight premature infants, as well as the safety of IBP-9414 vs. placebo. The study is powered on the necrotizing enterocolitis endpoint. ;Secondary Objective: To evaluate the effect of IBP-9414 on different severities of NEC, all cause mortality, duration of hospitalization, growth and feeding tolerance in very low birth weight premature infants. ;Primary end point(s): There are 2 primary endpoints: Primary Endpoint 1: Confirmed NEC Necrotizing enterocolitis (NEC) from the first dose until the infant reaches 34 weeks + 6 days post-menstrual age (PMA), where a NEC event is diagnosed by one of the following: A. At least one clinical sign of NEC as reported by the investigator AND abdominal X-ray evidence of intestinal pneumatosis and/or portal venous gas confirmed by independent adjudication. OR B. Surgery (or autopsy) with confirmation of necrotizing enterocolitis. Primary Endpoint 2: Time to sustained feeding tolerance measured as the number of days from the first dose to the first day (Day F) when: 1) criteria A and B are fulfilled: A)enteral feeding at =120 ml/kg/day every day until the subject reaches 34w+6d post menstrual age or is discharged if earlier. B)no use of parenteral nutrition (defined as intravenous use of any macronutrients (amino and/or lipids)) until the subject reaches 34w+6d post menstrual age or is discharged if earlier. and 2) where there is weight gain between Day F and the day the subject reaches 34w+6d post menstrual age or is discharged if earlier. ;Timepoint(s) of evaluation of this end point: daily	—

Measure

Time frame

Main Objective: To evaluate the efficacy of IBP-9414 vs. placebo on the prevention of necrotizing enterocolitis and on sustained feeding tolerance in very low birth weight premature infants, as well as the safety of IBP-9414 vs. placebo. The study is powered on the necrotizing enterocolitis endpoint. ;Secondary Objective: To evaluate the effect of IBP-9414 on different severities of NEC, all cause mortality, duration of hospitalization, growth and feeding tolerance in very low birth weight premature infants. ;Primary end point(s): There are 2 primary endpoints: Primary Endpoint 1: Confirmed NEC Necrotizing enterocolitis (NEC) from the first dose until the infant reaches 34 weeks + 6 days post-menstrual age (PMA), where a NEC event is diagnosed by one of the following: A. At least one clinical sign of NEC as reported by the investigator AND abdominal X-ray evidence of intestinal pneumatosis and/or portal venous gas confirmed by independent adjudication. OR B. Surgery (or autopsy) with confirmation of necrotizing enterocolitis. Primary Endpoint 2: Time to sustained feeding tolerance measured as the number of days from the first dose to the first day (Day F) when: 1) criteria A and B are fulfilled: A)enteral feeding at =120 ml/kg/day every day until the subject reaches 34w+6d post menstrual age or is discharged if earlier. B)no use of parenteral nutrition (defined as intravenous use of any macronutrients (amino and/or lipids)) until the subject reaches 34w+6d post menstrual age or is discharged if earlier. and 2) where there is weight gain between Day F and the day the subject reaches 34w+6d post menstrual age or is discharged if earlier. ;Timepoint(s) of evaluation of this end point: daily

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Secondary

Measure	Time frame
Secondary end point(s): 1. At least one clinical sign of NEC as reported by the investigator AND abdominal X-ray evidence of intestinal pneumatosis and/or portal venous gas confirmed by independent adjudication. 2. Surgery (or autopsy) with confirmation of necrotizing enterocolitis. 3. Death all causes 4. Number of days of hospitalization measured in the period from first dose to 34 weeks + 6 days PMA. 5. Weight gain in g/kg during weeks 3 and 4 of age. 6. Number of subjects growing at =100 g/kg/week measured during weeks 3 and 4 of age. 7. Days with clinical signs of feeding intolerance as reported in case record form by investigator measured from the first dose of study product to 34 weeks + 6 days post-menstrual age. ;Timepoint(s) of evaluation of this end point: daily	—

Measure

Time frame

Secondary end point(s): 1. At least one clinical sign of NEC as reported by the investigator AND abdominal X-ray evidence of intestinal pneumatosis and/or portal venous gas confirmed by independent adjudication. 2. Surgery (or autopsy) with confirmation of necrotizing enterocolitis. 3. Death all causes 4. Number of days of hospitalization measured in the period from first dose to 34 weeks + 6 days PMA. 5. Weight gain in g/kg during weeks 3 and 4 of age. 6. Number of subjects growing at =100 g/kg/week measured during weeks 3 and 4 of age. 7. Days with clinical signs of feeding intolerance as reported in case record form by investigator measured from the first dose of study product to 34 weeks + 6 days post-menstrual age. ;Timepoint(s) of evaluation of this end point: daily

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Countries

Bulgaria, France, Hungary, Israel, Poland, Romania, Spain, United Kingdom, United States

Contacts

Public ContactClinical Developement

Infant Bacterial Therapeutics AB (IBT)

clinical@ibtherapeutics.com+46 72 448 7358

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026