IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study
- Conditions
- Necrotizing Enterocolitis
- Interventions
- Drug: Placebo
- Registration Number
- NCT03978000
- Lead Sponsor
- Infant Bacterial Therapeutics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 2158
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IBP-9414 IBP-9414 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Surgery (or autopsy) with confirmation of NEC 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 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 Death all causes From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age Days with clinical signs of feeding intolerance 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 Number of subjects growing at ≥100 g/kg/week Weeks 3 and 4 of age
Trial Locations
- Locations (89)
University of Debrecen Clinical Center
🇭🇺Debrecen, Hungary
University of Szeged, Albert Szent-Györgyi Health Centre
🇭🇺Szeged, Hungary
Rambam Hospital
🇮🇱Haifa, Israel
Uniwersyteckie Centrum Kliniczne, Warszawskiego Uniwersytetu Medycznego
🇵🇱Warsaw, Poland
Veszprém County Csolnoky Ferenc Hospital
🇭🇺Veszprém, Hungary
University of Texas Medical Branch - Ocr
🇺🇸Galveston, Texas, United States
Good Samaritan Hospital
🇺🇸Los Angeles, California, United States
Sheridan Clinical Research / Plantation General Hospital
🇺🇸Plantation, Florida, United States
Loma Linda University Children Hospital
🇺🇸Loma Linda, California, United States
Children'S Hospital of the University of Illinois
🇺🇸Chicago, Illinois, United States
Harvard Medical School - Beth Israel Deaconess Medical Center (Bidmc)
🇺🇸Boston, Massachusetts, United States
University of Miami/Holtz Children'S Hospital
🇺🇸Miami, Florida, United States
Children'S Minnesota
🇺🇸Minneapolis, Minnesota, United States
Duke University
🇺🇸Durham, North Carolina, United States
North Central Baptist Hospital
🇺🇸San Antonio, Texas, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
LAC & USC Medical Center
🇺🇸Los Angeles, California, United States
University of Califorina, Los Angeles (UCLA)
🇺🇸Los Angeles, California, United States
North Shore University Health System
🇺🇸Evanston, Illinois, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
Connecticut Children'S Medical Center - Uconn - School of Medicine
🇺🇸Hartford, Connecticut, United States
Georgia Regents University
🇺🇸Augusta, Georgia, United States
Uf Health Jacksonville
🇺🇸Jacksonville, Florida, United States
Wolfson Children'S Hospital
🇺🇸Jacksonville, Florida, 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
Geisinger Health
🇺🇸Danville, Pennsylvania, United States
Cohen Children'S Medical Center of Ny
🇺🇸New Hyde Park, New York, United States
Kings County Hospital Center
🇺🇸Brooklyn, New York, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Maria Fareri Children's Hospital - Westchester Medical Center
🇺🇸Valhalla, New York, United States
New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States
Specialized Hospital in Active Treatment of Pediatric Diseases
🇧🇬Sofia, Bulgaria
Texas Health Presbyterian Hospital - Plano
🇺🇸Plano, Texas, United States
West Virginia University Medical Center
🇺🇸Morgantown, West Virginia, United States
Sheridan Healthcare of Texas, P.A./Medical City Plano
🇺🇸Plano, Texas, United States
Hopital Louis Mourier
🇫🇷Colombes, France
Bács-Kiskun County Hospital
🇭🇺Kecskemét, Hungary
Szszb County Hospital and Jósa András University Teaching Hospital
🇭🇺Nyiregyhaza, Hungary
Carmel Medical Center
🇮🇱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
Uniwersytecki Szpital Kliniczny
🇵🇱Wrocław, Poland
Children's Clinic of the Clinical Center of Kragujevac
🇷🇸Kragujevac, Serbia
Hospital General de Alicante
🇪🇸Alicante, Spain
Hospital Universitario La Fe
🇪🇸Valencia, Spain
Hospital Juan XXIII
🇪🇸Tarragona, Spain
Chu Amiens-Picardie - Site Sud
🇫🇷Amiens, France
Centre Hospitalier Universitaire de Caen Normandie
🇫🇷Caen, France
Hospital Universitario Hm Puerta Del Sur
🇪🇸Madrid, Spain
St. Joseph'S Women'S Hospital
🇺🇸Tampa, Florida, United States
Children'S Hospital At Ou Medicine
🇺🇸Oklahoma City, Oklahoma, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Children's Hospital of Michigan
🇺🇸Detroit, Michigan, United States
Valley Childrens Hospital
🇺🇸Madera, California, United States
SIU School of Medicine - HSHS St. John's Children's Hospital
🇺🇸Springfield, Illinois, United States
Hospital Clinico San Carlos - Idissc
🇪🇸Madrid, Spain
St. Francis Medical Center
🇺🇸Colorado Springs, Colorado, United States
Helen DeVos Children's Hospital Spectrum Health Research
🇺🇸Grand Rapids, Michigan, United States
Northwell Health Cohen Children'S Medical Center of Ny
🇺🇸New York, New York, United States
Associates in Newborn Medicine - Saint Paul
🇺🇸Saint Paul, Minnesota, United States
Acibadem City Clinic Tokuda Hospital (Tokushukai Medical Corporation - Tokuda Hospital Sofia) (THS)
🇧🇬Sofia, Bulgaria
Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timisoara
🇷🇴Timişoara, Romania
Szent György University Teaching Hospital of County Fejér
🇭🇺Székesfehérvár, Hungary
Nottingham University Hospitals, Neonatology: City Campus
🇬🇧Nottingham, United Kingdom
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
C.S Mott Children'S Hospital
🇺🇸Ann Arbor, Michigan, United States
Wake Health Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
St David'S Health Care - St. David'S Medical Center/North Austin Medical Center
🇺🇸Austin, Texas, United States
Children's Hospital of Richmind at VCU
🇺🇸Richmond, Virginia, United States
University Hospital of Obstetrics and Gynecology Maichin Dom - Neonatology Clinic
🇧🇬Sofia, Bulgaria
University of Tennessee Health Science Center
🇺🇸Memphis, Tennessee, United States
University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski" - Clinic of Neonatology
🇧🇬Pleven, Bulgaria
Spitalul Clinic de Obstetrica si Ginecologie "Filantropia"
🇷🇴Bukarest, Romania
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
🇷🇴Cluj-Napoca, Romania
Jackson Madison County General Hospital
🇺🇸Jackson, Tennessee, United States
Medical University of South Carolina (MUSC)
🇺🇸Charleston, South Carolina, United States
University Multiprofile Hospital for Active Treatment
🇧🇬Plovdiv, Bulgaria
Borsod- Abaúj-Zemplén County Central Hospital and University Teaching Hospital
🇭🇺Miskolc, Hungary
Samodzielny Publiczny Szpital Kliniczny nr 2 Pomorski Uniwersytet Medyczny (PUM) w Szczecinie /Pomeranian Medical University
🇵🇱Szczecin, Poland
Spitalul Clinic de Obstetrica-Ginecologie "Cuza-Voda" Iasi
🇷🇴Iaşi, Romania
Spitalul Clinic Municipal de Urgenta Timisoara
🇷🇴Timişoara, Romania
Children'S Hospital At Montefiore
🇺🇸Bronx, New York, United States
University of Florida Health
🇺🇸Gainesville, Florida, United States
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