This study is in progress, not accepting new patients

IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study

a study on Necrotizing Enterocolitis Premature Birth

Summary

Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Meena Garg

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, 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)
    Los Angeles California 90095 United States
  • Good Samaritan Hospital
    Los Angeles California 90017 United States
  • LAC & USC Medical Center
    Los Angeles California 90033 United States

Lead Scientist at UCLA

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Infant Bacterial Therapeutics
ID
NCT03978000
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 2158 people participating
Last Updated