Summary

Location
at UCLA
Dates
study started
estimated completion

Description

Summary

IBP-9414 will be evaluated in preterm infants with a birth weight of 500-1500g, compared to placebo with regards to efficacy and safety in the prevention of necrotizing enterocolitis.

Official Title

A Randomized, Double Blind, Parallel-group, Placebo Controlled Study to Evaluate the Efficacy and Safety of IBP-9414 in Premature Infants 500-1500g Birth Weight in the Prevention of Necrotizing Enterocolitis - The Connection Study

Keywords

Necrotizing Enterocolitis Enterocolitis Enterocolitis, Necrotizing IBP-9414

Eligibility

You can join if…

  • Gestational age at birth of 23 weeks+0 days to 32 weeks+0 days
  • Birth weight 500-1500g
  • ≤ 48 hours of age
  • Written informed consent from the subject´s legally authorized representative (LAR)

You CAN'T join if...

  • 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

Locations

  • University of Califorina, Los Angeles (UCLA) accepting new patients
    Los Angeles California 90095 United States
  • Good Samaritan Hospital accepting new patients
    Los Angeles California 90017 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Infant Bacterial Therapeutics
ID
NCT03978000
Phase
Phase 3
Study Type
Interventional
Last Updated