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IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study
About
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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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
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Study Stats
Protocol No.
18-001826
Category
Pediatric and Prenatal Disorders
Principal Investigator
Contact
Location
- UCLA Santa Monica
- UCLA Westwood