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ACTIVE NOT RECRUITING
NCT03978000
PHASE3

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

Sponsor: Infant Bacterial Therapeutics

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - 48 Hours

Study Type

INTERVENTIONAL

Enrollment

2158

Start Date

2019-07-04

Completion Date

2024-07

Last Updated

2024-04-12

Healthy Volunteers

No

Interventions

DRUG

IBP-9414

Oral suspension

DRUG

Placebo

Sterile water

Locations (89)

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