IBP-9414 for the Prevention of Necrotizing Enterocolitis

A Randomized, Double Blind, Parallel-group, Dose Escalation Placebo-controlled Multicenter Study to Investigate the Safety and Tolerability of IBP-9414 Administered in Preterm Infants.

Two different dose levels will be evaluated in two different birth weight categories, compared to placebo with regards to safety and tolerability.

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.