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

NCT03978000 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: IBP-9414-020
• Study Type: interventional
• Target: 2,158
• Locations: 10 countries
• Sites: 89

Brief 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

Necrotizing Enterocolitis

Outcome Measures

Primary Outcomes (2)

• Confirmed necrotizing enterocolitis (NEC)

  From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age

• Time to sustained feeding tolerance

  From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age

Secondary Outcomes (7)

• At least one clinical sign of NEC as reported by the investigator AND abdominal X-ray evidence of intestinal pneumatosis and/or portal venous gas confirmed by independent adjudication.

  From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age

• Surgery (or autopsy) with confirmation of NEC

  From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age

• Death all causes

  From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age

• Number of days of hospitalization

  From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age

• Weight gain in g/kg

  Weeks 3 and 4 of age

Study Arms (2)

IBP-9414

ACTIVE COMPARATOR

Drug: IBP-9414

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

IBP-9414 DRUG

Oral suspension

IBP-9414

Placebo DRUG

Sterile water

Placebo

Eligibility Criteria

• Age: Up to 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age at birth of 23 weeks+0 days to 32 weeks+0 days
• Birth weight 500-1500g
• ≤ 48 hours of age
• Written informed consent from the subject´s legally authorized representative (LAR)

You may not qualify if:

• Participation in any other interventional clinical trial
• 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

Sponsors & Collaborators

• Infant Bacterial Therapeutics: lead

Study Sites (89)

Banner University Medical Center / University of Arizona

Tucson, Arizona, 85724, United States

Location

Arkansas Children'S Hospital

Little Rock, Arkansas, 72205, United States

Location

University of Arkansas For Medical Services

Little Rock, Arkansas, 72205, United States

Location

Loma Linda University Children Hospital

Loma Linda, California, 11234, United States

Location

Good Samaritan Hospital

Los Angeles, California, 90017, United States

Location

LAC & USC Medical Center

Los Angeles, California, 90033, United States

Location

University of Califorina, Los Angeles (UCLA)

Los Angeles, California, 90095, United States

Location

Valley Childrens Hospital

Madera, California, 93636, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

St. Francis Medical Center

Colorado Springs, Colorado, 80923, United States

Location

Connecticut Children'S Medical Center - Uconn - School of Medicine

Hartford, Connecticut, 06106, United States

Location

University of Florida Health

Gainesville, Florida, 32610, United States

Location

Wolfson Children'S Hospital

Jacksonville, Florida, 32207, United States

Location

Uf Health Jacksonville

Jacksonville, Florida, 32209, United States

Location

University of Miami/Holtz Children'S Hospital

Miami, Florida, 33136, United States

Location

Sheridan Clinical Research / Plantation General Hospital

Plantation, Florida, 33323, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

St. Joseph'S Women'S Hospital

Tampa, Florida, 33607, United States

Location

Georgia Regents University

Augusta, Georgia, 30912, United States

Location

Children'S Hospital of the University of Illinois

Chicago, Illinois, 60612, United States

Location

North Shore University Health System

Evanston, Illinois, 60201, United States

Location

SIU School of Medicine - HSHS St. John's Children's Hospital

Springfield, Illinois, 62769, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Tufts Children's Hospital

Boston, Massachusetts, 02111, United States

Location

Harvard Medical School - Beth Israel Deaconess Medical Center (Bidmc)

Boston, Massachusetts, 02215, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

C.S Mott Children'S Hospital

Ann Arbor, Michigan, 48109, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Helen DeVos Children's Hospital Spectrum Health Research

Grand Rapids, Michigan, 49503, United States

Location

Children'S Minnesota

Minneapolis, Minnesota, 55404, United States

Location

Associates in Newborn Medicine - Saint Paul

Saint Paul, Minnesota, 55102, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Kings County Hospital Center

Brooklyn, New York, 11203, United States

Location

Cohen Children'S Medical Center of Ny

New Hyde Park, New York, 11040, United States

Location

Northwell Health Cohen Children'S Medical Center of Ny

New York, New York, 11040, United States

Location

Children'S Hospital At Montefiore

The Bronx, New York, 10461, United States

Location

Maria Fareri Children's Hospital - Westchester Medical Center

Valhalla, New York, 10595, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

New Hanover Regional Medical Center

Wilmington, North Carolina, 28401, United States

Location

Wake Health Forest Baptist Health

Winston-Salem, North Carolina, 27012, United States

Location

Children'S Hospital At Ou Medicine

Oklahoma City, Oklahoma, 73104, United States

Location

Geisinger Health

Danville, Pennsylvania, 17822, United States

Location

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

Location

Jackson Madison County General Hospital

Jackson, Tennessee, 38301, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

St David'S Health Care - St. David'S Medical Center/North Austin Medical Center

Austin, Texas, 78705, United States

Location

University of Texas Medical Branch - Ocr

Galveston, Texas, 77555, United States

Location

Texas Health Presbyterian Hospital - Plano

Plano, Texas, 75024, United States

Location

Sheridan Healthcare of Texas, P.A./Medical City Plano

Plano, Texas, 75075-6199, United States

Location

North Central Baptist Hospital

San Antonio, Texas, 78258, United States

Location

Children's Hospital of Richmind at VCU

Richmond, Virginia, 23298, United States

Location

West Virginia University Medical Center

Morgantown, West Virginia, 26506, United States

Location

University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski" - Clinic of Neonatology

Pleven, Bulgaria

Location

University Multiprofile Hospital for Active Treatment

Plovdiv, Bulgaria

Location

Acibadem City Clinic Tokuda Hospital (Tokushukai Medical Corporation - Tokuda Hospital Sofia) (THS)

Sofia, Bulgaria

Location

Specialized Hospital in Active Treatment of Pediatric Diseases

Sofia, Bulgaria

Location

University Hospital of Obstetrics and Gynecology Maichin Dom - Neonatology Clinic

Sofia, Bulgaria

Location

Chu Amiens-Picardie - Site Sud

Amiens, France

Location

Centre Hospitalier Universitaire de Caen Normandie

Caen, France

Location

Hopital Louis Mourier

Colombes, France

Location

University of Debrecen Clinical Center

Debrecen, 4032, Hungary

Location

Bács-Kiskun County Hospital

Kecskemét, 6000, Hungary

Location

Borsod- Abaúj-Zemplén County Central Hospital and University Teaching Hospital

Miskolc, Hungary

Location

Szszb County Hospital and Jósa András University Teaching Hospital

Nyíregyháza, 4400, Hungary

Location

University of Szeged, Albert Szent-Györgyi Health Centre

Szeged, Hungary

Location

Szent György University Teaching Hospital of County Fejér

Székesfehérvár, 8000, Hungary

Location

Veszprém County Csolnoky Ferenc Hospital

Veszprém, Hungary

Location

Carmel Medical Center

Haifa, Israel

Location

Rambam Hospital

Haifa, Israel

Location

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego im. prof. Tadeusza Sokołowskiego

Szczecin, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 2 Pomorski Uniwersytet Medyczny (PUM) w Szczecinie /Pomeranian Medical University

Szczecin, Poland

Location

Uniwersyteckie Centrum Kliniczne, Warszawskiego Uniwersytetu Medycznego

Warsaw, Poland

Location

Uniwersytecki Szpital Kliniczny

Wroclaw, Poland

Location

Spitalul Clinic de Obstetrica si Ginecologie "Filantropia"

Bucharest, Romania

Location

Spitalul Clinic Judetean de Urgenta Cluj-Napoca

Cluj-Napoca, Romania

Location

Spitalul Clinic de Obstetrica-Ginecologie "Cuza-Voda" Iasi

Iași, Romania

Location

Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timisoara

Timișoara, Romania

Location

Spitalul Clinic Municipal de Urgenta Timisoara

Timișoara, Romania

Location

Children's Clinic of the Clinical Center of Kragujevac

Kragujevac, Serbia

Location

Hospital General de Alicante

Alicante, Spain

Location

Hospital Clinico San Carlos - Idissc

Madrid, Spain

Location

Hospital Universitario Hm Puerta Del Sur

Madrid, Spain

Location

Hospital Juan XXIII

Tarragona, Spain

Location

Hospital Universitario La Fe

Valencia, Spain

Location

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Location

Nottingham University Hospitals, Neonatology: City Campus

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Josef Neu, MD

  University of Florida College of Medicine, Gainsville, FL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 6, 2019
• Study Start: July 4, 2019
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

IL (3); HU (7); US (54); PL (4); FR (3); ES (5); SE (1); BU (5); GB (2); RO (5)