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Not listed 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 May 20, 2026, 2:10 AM 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

Study identification

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

Conditions and interventions

Interventions

  • IBP-9414 Drug
  • Placebo Drug

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 3, 2019
Primary completion
May 31, 2024
Completion
Jun 30, 2024
Last update posted
Apr 11, 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 11, 2024 · Synced May 20, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03978000 live on ClinicalTrials.gov.

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