IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study
NCT ID: NCT03978000
Last Updated: 2024-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
2158 participants
INTERVENTIONAL
2019-07-04
2024-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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IBP-9414
IBP-9414
Oral suspension
Placebo
Placebo
Sterile water
Interventions
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IBP-9414
Oral suspension
Placebo
Sterile water
Eligibility Criteria
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Inclusion Criteria
* Birth weight 500-1500g
* ≤ 48 hours of age
* Written informed consent from the subject´s legally authorized representative (LAR)
Exclusion Criteria
* Infants in extremis to whom no further intensive care is offered by attending neonatologist
* Infants with, or at a high probability for, early onset sepsis
* Infants with recognized chromosomal anomalies
* Congenital or acquired gastrointestinal disease
* Earlier or planned administration of formulas, foods or supplements that contain added live bacteria
* Infants with known positive maternal HIV status
48 Hours
ALL
No
Sponsors
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Infant Bacterial Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Josef Neu, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida College of Medicine, Gainsville, FL
Locations
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Banner University Medical Center / University of Arizona
Tucson, Arizona, United States
Arkansas Children'S Hospital
Little Rock, Arkansas, United States
University of Arkansas For Medical Services
Little Rock, Arkansas, United States
Loma Linda University Children Hospital
Loma Linda, California, United States
Good Samaritan Hospital
Los Angeles, California, United States
LAC & USC Medical Center
Los Angeles, California, United States
University of Califorina, Los Angeles (UCLA)
Los Angeles, California, United States
Valley Childrens Hospital
Madera, California, United States
Sharp Memorial Hospital
San Diego, California, United States
St. Francis Medical Center
Colorado Springs, Colorado, United States
Connecticut Children'S Medical Center - Uconn - School of Medicine
Hartford, Connecticut, United States
University of Florida Health
Gainesville, Florida, United States
Wolfson Children'S Hospital
Jacksonville, Florida, United States
Uf Health Jacksonville
Jacksonville, Florida, United States
University of Miami/Holtz Children'S Hospital
Miami, Florida, United States
Sheridan Clinical Research / Plantation General Hospital
Plantation, Florida, United States
University of South Florida
Tampa, Florida, United States
St. Joseph'S Women'S Hospital
Tampa, Florida, United States
Georgia Regents University
Augusta, Georgia, United States
Children'S Hospital of the University of Illinois
Chicago, Illinois, United States
North Shore University Health System
Evanston, Illinois, United States
SIU School of Medicine - HSHS St. John's Children's Hospital
Springfield, Illinois, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Wesley Medical Center
Wichita, Kansas, United States
Tufts Children's Hospital
Boston, Massachusetts, United States
Harvard Medical School - Beth Israel Deaconess Medical Center (Bidmc)
Boston, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
C.S Mott Children'S Hospital
Ann Arbor, Michigan, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Helen DeVos Children's Hospital Spectrum Health Research
Grand Rapids, Michigan, United States
Children'S Minnesota
Minneapolis, Minnesota, United States
Associates in Newborn Medicine - Saint Paul
Saint Paul, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Kings County Hospital Center
Brooklyn, New York, United States
Cohen Children'S Medical Center of Ny
New Hyde Park, New York, United States
Northwell Health Cohen Children'S Medical Center of Ny
New York, New York, United States
Children'S Hospital At Montefiore
The Bronx, New York, United States
Maria Fareri Children's Hospital - Westchester Medical Center
Valhalla, New York, United States
Duke University
Durham, North Carolina, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, United States
Wake Health Forest Baptist Health
Winston-Salem, North Carolina, United States
Children'S Hospital At Ou Medicine
Oklahoma City, Oklahoma, United States
Geisinger Health
Danville, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Jackson Madison County General Hospital
Jackson, Tennessee, United States
University of Tennessee Health Science Center
Memphis, Tennessee, United States
St David'S Health Care - St. David'S Medical Center/North Austin Medical Center
Austin, Texas, United States
University of Texas Medical Branch - Ocr
Galveston, Texas, United States
Texas Health Presbyterian Hospital - Plano
Plano, Texas, United States
Sheridan Healthcare of Texas, P.A./Medical City Plano
Plano, Texas, United States
North Central Baptist Hospital
San Antonio, Texas, United States
Children's Hospital of Richmind at VCU
Richmond, Virginia, United States
West Virginia University Medical Center
Morgantown, West Virginia, United States
University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski" - Clinic of Neonatology
Pleven, , Bulgaria
University Multiprofile Hospital for Active Treatment
Plovdiv, , Bulgaria
Acibadem City Clinic Tokuda Hospital (Tokushukai Medical Corporation - Tokuda Hospital Sofia) (THS)
Sofia, , Bulgaria
Specialized Hospital in Active Treatment of Pediatric Diseases
Sofia, , Bulgaria
University Hospital of Obstetrics and Gynecology Maichin Dom - Neonatology Clinic
Sofia, , Bulgaria
Chu Amiens-Picardie - Site Sud
Amiens, , France
Centre Hospitalier Universitaire de Caen Normandie
Caen, , France
Hopital Louis Mourier
Colombes, , France
University of Debrecen Clinical Center
Debrecen, , Hungary
Bács-Kiskun County Hospital
Kecskemét, , Hungary
Borsod- Abaúj-Zemplén County Central Hospital and University Teaching Hospital
Miskolc, , Hungary
Szszb County Hospital and Jósa András University Teaching Hospital
Nyíregyháza, , Hungary
University of Szeged, Albert Szent-Györgyi Health Centre
Szeged, , Hungary
Szent György University Teaching Hospital of County Fejér
Székesfehérvár, , Hungary
Veszprém County Csolnoky Ferenc Hospital
Veszprém, , Hungary
Carmel Medical Center
Haifa, , Israel
Rambam Hospital
Haifa, , Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego im. prof. Tadeusza Sokołowskiego
Szczecin, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 2 Pomorski Uniwersytet Medyczny (PUM) w Szczecinie /Pomeranian Medical University
Szczecin, , Poland
Uniwersyteckie Centrum Kliniczne, Warszawskiego Uniwersytetu Medycznego
Warsaw, , Poland
Uniwersytecki Szpital Kliniczny
Wroclaw, , Poland
Spitalul Clinic de Obstetrica si Ginecologie "Filantropia"
Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Cluj-Napoca, , Romania
Spitalul Clinic de Obstetrica-Ginecologie "Cuza-Voda" Iasi
Iași, , Romania
Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timisoara
Timișoara, , Romania
Spitalul Clinic Municipal de Urgenta Timisoara
Timișoara, , Romania
Children's Clinic of the Clinical Center of Kragujevac
Kragujevac, , Serbia
Hospital General de Alicante
Alicante, , Spain
Hospital Clinico San Carlos - Idissc
Madrid, , Spain
Hospital Universitario Hm Puerta Del Sur
Madrid, , Spain
Hospital Juan XXIII
Tarragona, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Nottingham University Hospitals, Neonatology: City Campus
Nottingham, , United Kingdom
Countries
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Other Identifiers
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IBP-9414-020
Identifier Type: -
Identifier Source: org_study_id
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