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Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT03978000

Public ClinicalTrials.gov record NCT03978000. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 3:57 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03978000
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Infant Bacterial Therapeutics
Industry
Enrollment
2,158 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
Up to 48 Hours
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 4, 2019 (Actual)
Primary completion
Jun 2024 (Estimated)
Completion
Jul 2024 (Estimated)
Last update posted
Apr 12, 2024

2019 – 2024

United States locations

U.S. sites
54
U.S. states
24
U.S. cities
47
Facility City State ZIP Site status
Banner University Medical Center / University of Arizona Tucson Arizona 85724 —
Arkansas Children'S Hospital Little Rock Arkansas 72205 —
University of Arkansas For Medical Services Little Rock Arkansas 72205 —
Loma Linda University Children Hospital Loma Linda California 11234 —
Good Samaritan Hospital Los Angeles California 90017 —
LAC & USC Medical Center Los Angeles California 90033 —
University of Califorina, Los Angeles (UCLA) Los Angeles California 90095 —
Valley Childrens Hospital Madera California 93636 —
Sharp Memorial Hospital San Diego California 92123 —
St. Francis Medical Center Colorado Springs Colorado 80923 —
Connecticut Children'S Medical Center - Uconn - School of Medicine Hartford Connecticut 06106 —
University of Florida Health Gainesville Florida 32610 —
Wolfson Children'S Hospital Jacksonville Florida 32207 —
Uf Health Jacksonville Jacksonville Florida 32209 —
University of Miami/Holtz Children'S Hospital Miami Florida 33136 —
Sheridan Clinical Research / Plantation General Hospital Plantation Florida 33323 —
University of South Florida Tampa Florida 33606 —
St. Joseph'S Women'S Hospital Tampa Florida 33607 —
Georgia Regents University Augusta Georgia 30912 —
Children'S Hospital of the University of Illinois Chicago Illinois 60612 —
North Shore University Health System Evanston Illinois 60201 —
SIU School of Medicine - HSHS St. John's Children's Hospital Springfield Illinois 62769 —
Memorial Hospital of South Bend South Bend Indiana 46601 —
Wesley Medical Center Wichita Kansas 67214 —
Tufts Children's Hospital Boston Massachusetts 02111 —
Harvard Medical School - Beth Israel Deaconess Medical Center (Bidmc) Boston Massachusetts 02215 —
Baystate Medical Center Springfield Massachusetts 01199 —
C.S Mott Children'S Hospital Ann Arbor Michigan 48109 —
Children's Hospital of Michigan Detroit Michigan 48201 —
Helen DeVos Children's Hospital Spectrum Health Research Grand Rapids Michigan 49503 —
Children'S Minnesota Minneapolis Minnesota 55404 —
Associates in Newborn Medicine - Saint Paul Saint Paul Minnesota 55102 —
University of Mississippi Medical Center Jackson Mississippi 39216 —
Hackensack University Medical Center Hackensack New Jersey 07601 —
Kings County Hospital Center Brooklyn New York 11203 —
Cohen Children'S Medical Center of Ny New Hyde Park New York 11040 —
Northwell Health Cohen Children'S Medical Center of Ny New York New York 11040 —
Children'S Hospital At Montefiore The Bronx New York 10461 —
Maria Fareri Children's Hospital - Westchester Medical Center Valhalla New York 10595 —
Duke University Durham North Carolina 27705 —
New Hanover Regional Medical Center Wilmington North Carolina 28401 —
Wake Health Forest Baptist Health Winston-Salem North Carolina 27012 —
Children'S Hospital At Ou Medicine Oklahoma City Oklahoma 73104 —
Geisinger Health Danville Pennsylvania 17822 —
Medical University of South Carolina (MUSC) Charleston South Carolina 29425 —
Jackson Madison County General Hospital Jackson Tennessee 38301 —
University of Tennessee Health Science Center Memphis Tennessee 38163 —
St David'S Health Care - St. David'S Medical Center/North Austin Medical Center Austin Texas 78705 —
University of Texas Medical Branch - Ocr Galveston Texas 77555 —
Texas Health Presbyterian Hospital - Plano Plano Texas 75024 —
Sheridan Healthcare of Texas, P.A./Medical City Plano Plano Texas 75075-6199 —
North Central Baptist Hospital San Antonio Texas 78258 —
Children's Hospital of Richmind at VCU Richmond Virginia 23298 —
West Virginia University Medical Center Morgantown West Virginia 26506 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 35 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03978000, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 12, 2024 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03978000 live on ClinicalTrials.gov.

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