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

NCT03978000 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2158

Last updated 2024-04-12

No results posted yet for this study

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.

Conditions

  • Necrotizing Enterocolitis

Interventions

DRUG

IBP-9414

Oral suspension

DRUG

Placebo

Sterile water

Sponsors & Collaborators

  • Infant Bacterial Therapeutics

    lead INDUSTRY

Principal Investigators

  • Josef Neu, MD · University of Florida College of Medicine, Gainsville, FL

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-04
Primary Completion
2024-06-30
Completion
2024-07-31
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • France
  • Hungary
  • Israel
  • Poland
  • Romania
  • Serbia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03978000 on ClinicalTrials.gov