IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study

Study Overview
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Brief Summary
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IBP-9414 will be evaluated in preterm infants with a birth weight of 500-1500g, compared to placebo with regards to efficacy and safety in the prevention of necrotizing enterocolitis.

Official Title
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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

Conditions
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Necrotizing Enterocolitis

Intervention / Treatment
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* Drug: IBP-9414
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age at birth of 23 weeks+0 days to 32 weeks+0 days Birth weight 500-1500g ≤ 48 hours of age Written informed consent from the subject´s legally authorized representative (LAR) Exclusion Criteria: Participation in any other interventional clinical trial Infants in extremis to whom no further intensive care is offered by attending neonatologist Infants with, or at a high probability for, early onset sepsis Infants with recognized chromosomal anomalies Congenital or acquired gastrointestinal disease Earlier or planned administration of formulas, foods or supplements that contain added live bacteria Infants with known positive maternal HIV status

Ages Eligible for Study
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Maximum Age: 48 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IBP-9414<br> | Drug: IBP-9414<br>* Oral suspension<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Sterile water<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmed necrotizing enterocolitis (NEC) |  | From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age | 
| Time to sustained feeding tolerance |  | From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age | 
| Surgery (or autopsy) with confirmation of NEC |  | From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age | 
| Death all causes |  | From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age | 
| Number of days of hospitalization |  | From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age | 
| Weight gain in g/kg |  | Weeks 3 and 4 of age | 
| Number of subjects growing at ≥100 g/kg/week |  | Weeks 3 and 4 of age | 
| Days with clinical signs of feeding intolerance |  | From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age |