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

OPEN TO ACCRUAL
Up to 48 hours old
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
Drug: IBP-9414, Drug: Placebo, drug: Ibp-9414
Necrotizing Enterocolitis, Certain Conditions Originating in the Perinatal Period (760-779)
Subotic, Aleksander - aleksandar.subotic@vcuhealth.org
Moores, Russell, Ray
III
HM20018843
NCT03978000
See this study on ClinicalTrials.gov