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

Location: at UCLA
Dates: study started July 2019
completion around July 2024

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
Sharp Memorial Hospital
San Diego California 92123 United States
Good Samaritan Hospital
Los Angeles California 90017 United States
LAC & USC Medical Center
Los Angeles California 90033 United States
Valley Childrens Hospital
Madera California 93636 United States

Details

Status: in progress, not accepting new patients
Start Date: July 2019
Completion Date: July 2024 (estimated)
Sponsor: Infant Bacterial Therapeutics
ID: NCT03978000
Phase: Phase 3 research study
Study Type: Interventional
Participants: About 2158 people participating
Last Updated: April 2024