Trial | NCT02472769  Report issue

Title

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

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    120
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
2016
Primary Completion
Aug 07
2017
Study Completion
Aug 07
2017
Last Update
Dec 29
2017

Drug IBP-9414

Drug Placebo

Sterile water

IBP-9414 Active Comparator

IBP-9414 Oral Daily

Placebo Placebo Comparator

Sterile water

Criteria 

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