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

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