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IBP-9414 for the Prevention of Necrotizing Enterocolitis

NCT02472769 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-12-29

No results posted yet for this study

Summary

Two different dose levels will be evaluated in two different birth weight categories, compared to placebo with regards to safety and tolerability.

Conditions

  • Necrotizing Enterocolitis

Interventions

DRUG

IBP-9414

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
2016-05-27
Primary Completion
2017-08-07
Completion
2017-08-07

Countries

  • United States

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 NCT02472769 on ClinicalTrials.gov