IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study
Purpose
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.
Condition
- Necrotizing Enterocolitis
Eligibility
- Eligible Ages
- Under 48 Hours
- Eligible Genders
- All
- Accepts 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator IBP-9414 |
|
|
Placebo Comparator Placebo |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- Infant Bacterial Therapeutics