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.
  • Phase

    Phase 2
  • Study Type

  • Status

    Completed No Results Posted
  • Study Participants

Two different dose levels will be evaluated in two different birth weight categories, compared to placebo with regards to safety and tolerability.
Study Started
May 27
Primary Completion
Aug 07
Study Completion
Aug 07
Last Update
Dec 29

Drug IBP-9414

Drug Placebo

Sterile water

IBP-9414 Active Comparator

IBP-9414 Oral Daily

Placebo Placebo Comparator

Sterile water


Inclusion Criteria:

Gestational age ≤32 weeks
Birth weight: a) ≤ 2,000 g and b) ≤ 1,000 g.
< 48 hours of age.
Written informed consent from the patient's legally authorized representative(s).

Exclusion Criteria:

Participation in an additional interventional clinical trial in which an investigational drug will be administered.
Infants in extremis to whom no further intensive care is offered by attending neonatologist (e.g., infant being provided only hospice/comfort care).
Congenital or acquired gastrointestinal pathology.
Other conditions of the infant, which in the opinion of the attending neonatologist, preclude participation.
No Results Posted