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NCT03978000 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Necrotizing Enterocolitis, sponsored by Infant Bacterial Therapeutics.

Active
Registry status
Phase 3
Development phase
2,158
Enrollment target
20
Study locations

NCT03978000 is a Phase 3 study of Necrotizing Enterocolitis that is active but no longer recruiting, run by Infant Bacterial Therapeutics. The registered enrollment target is 2,158 participants, above the 159-participant average among 14 other Necrotizing Enterocolitis trials with a reported enrollment target (1257% higher). The trial reports 20 study locations across 8 states.

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The verdict

NCT03978000, a Phase 3 study of Necrotizing Enterocolitis, is active but no longer recruiting, sponsored by Infant Bacterial Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
2,158 participants
Enrollment target
20
Study locations

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 Studied

Necrotizing Enterocolitis

Interventions

  • DRUG Placebo
  • DRUG IBP-9414

Study Locations (20)

Florida

  • University of Florida Health - Gainesville
  • Wolfson Children'S Hospital - Jacksonville
  • Uf Health Jacksonville - Jacksonville
  • University of Miami/Holtz Children'S Hospital - Miami
  • Sheridan Clinical Research / Plantation General Hospital - Plantation
  • University of South Florida - Tampa
  • St. Joseph'S Women'S Hospital - Tampa

California

  • Loma Linda University Children Hospital - Loma Linda
  • Good Samaritan Hospital - Los Angeles
  • LAC & USC Medical Center - Los Angeles
  • University of Califorina, Los Angeles (UCLA) - Los Angeles
  • Valley Childrens Hospital - Madera
  • Sharp Memorial Hospital - San Diego

Arkansas

  • Arkansas Children'S Hospital - Little Rock
  • University of Arkansas For Medical Services - Little Rock

Arizona

  • Banner University Medical Center / University of Arizona - Tucson

Colorado

  • St. Francis Medical Center - Colorado Springs

Connecticut

  • Connecticut Children'S Medical Center - Uconn - School of Medicine - Hartford

Georgia

  • Georgia Regents University - Augusta

Illinois

  • Children'S Hospital of the University of Illinois - Chicago

Trial Details

FieldValue
Enrollment Target 2,158 participants
Start Date 2019-07-04
Est. Completion 2024-07
Phase Phase 3

Sponsor

Infant Bacterial Therapeutics

2 total trials

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What the Registry Record Tells You About NCT03978000

The ClinicalTrials.gov registry entry for NCT03978000 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 2,158 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 159-participant average among 14 other Necrotizing Enterocolitis trials with a reported enrollment target (1257% higher). The listed sponsor is Infant Bacterial Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Necrotizing Enterocolitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT03978000 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Florida, California, Arkansas.

Frequently Asked Questions

What is clinical trial NCT03978000 about?

NCT03978000 is a clinical study titled "IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study". 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.

What is the current status of trial NCT03978000?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 2,158 participants. The study started on 2019-07-04. Estimated completion is 2024-07.

What conditions does trial NCT03978000 study?

This clinical trial studies the following conditions: Necrotizing Enterocolitis.

What interventions are being tested in trial NCT03978000?

The interventions under investigation include: Placebo (DRUG), IBP-9414 (DRUG).

Who is sponsoring clinical trial NCT03978000?

This trial is sponsored by Infant Bacterial Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03978000 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.