IBP-9414 for the Prevention of Necrotizing Enterocolitis

Inclusion Criteria:

1. Gestational age ≤32 weeks

2. Birth weight: a) ≤ 2,000 g and b) ≤ 1,000 g.

3. < 48 hours of age.

4. Written informed consent from the patient's legally authorized representative(s).

Exclusion Criteria:

1. Participation in an additional interventional clinical trial in which an
investigational drug will be administered.

2. Infants in extremis to whom no further intensive care is offered by attending
neonatologist (e.g., infant being provided only hospice/comfort care).

3. Congenital or acquired gastrointestinal pathology.

4. Other conditions of the infant, which in the opinion of the attending neonatologist,
preclude participation.