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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: Active Phase 3 study of Necrotizing Enterocolitis, sponsored by Infant Bacterial Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 2,158 participants |
| Start Date | 2019-07-04 |
| Est. Completion | 2024-07 |
| Phase | Phase 3 |
What the registry record for NCT03978000 still lists
NCT03978000 is an interventional study that assigns participants to a tested intervention. Its 2,158 participants enrollment target places it among the larger protocols in the corpus, above the 159-participant average among 14 other Necrotizing Enterocolitis trials with a reported enrollment target (1257% higher).
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 names 20 study sites across 8 states, led by 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.
Learn More About Clinical Trials
Similar trials for Necrotizing Enterocolitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03978000's enrollment target sits among peer trials
2,158 1st of 14 higher than 14 of 14 other Necrotizing Enterocolitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Necrotizing Enterocolitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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