Necrotizing Enterocolitis
Conditions
Brief summary
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.
Interventions
DRUGPlacebo
Sterile water
DRUGIBP-9414
Oral suspension
Sponsors
Infant Bacterial Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 48 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| Weight gain in g/kg | Weeks 3 and 4 of age |
| Surgery (or autopsy) with confirmation of NEC | From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age |
Countries
Bulgaria, France, Hungary, Israel, Poland, Romania, Serbia, Spain, United Kingdom, United States
Outcome results
None listed