Clinical trial NCT03978000: IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study
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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Necrotizing Enterocolitis
Lead sponsor: Infant Bacterial Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-06-06
Enrollment: 2158
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Confirmed necrotizing enterocolitis (NEC)
timeFrame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
measure: Time to sustained feeding tolerance
timeFrame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Secondary outcomes:
measure: 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.
timeFrame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
measure: Surgery (or autopsy) with confirmation of NEC
timeFrame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
measure: Death all causes
timeFrame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
measure: Number of days of hospitalization
timeFrame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
measure: Weight gain in g/kg
timeFrame: Weeks 3 and 4 of age
measure: Number of subjects growing at ≥100 g/kg/week
timeFrame: Weeks 3 and 4 of age
measure: Days with clinical signs of feeding intolerance
timeFrame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University Medical Center / University of Arizona
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Children'S Hospital
state: Arkansas
city: Little Rock
country: United States
facility: University of Arkansas For Medical Services
state: Arkansas
city: Loma Linda
country: United States
facility: Loma Linda University Children Hospital
state: California
city: Los Angeles
country: United States
facility: Good Samaritan Hospital
state: California
city: Los Angeles
country: United States
facility: LAC & USC Medical Center
state: California
city: Los Angeles
country: United States
facility: University of Califorina, Los Angeles (UCLA)
state: California
city: Madera
country: United States
facility: Valley Childrens Hospital
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Colorado Springs
country: United States
facility: St. Francis Medical Center
state: Colorado
city: Hartford
country: United States
facility: Connecticut Children'S Medical Center - Uconn - School of Medicine
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida Health
state: Florida
city: Jacksonville
country: United States
facility: Wolfson Children'S Hospital
state: Florida
city: Jacksonville
country: United States
facility: Uf Health Jacksonville
state: Florida
city: Miami
country: United States
facility: University of Miami/Holtz Children'S Hospital
state: Florida
city: Plantation
country: United States
facility: Sheridan Clinical Research / Plantation General Hospital
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Tampa
country: United States
facility: St. Joseph'S Women'S Hospital
state: Florida
city: Augusta
country: United States
facility: Georgia Regents University
state: Georgia
city: Chicago
country: United States
facility: Children'S Hospital of the University of Illinois
state: Illinois
city: Evanston
country: United States
facility: North Shore University Health System
state: Illinois
city: Springfield
country: United States
facility: SIU School of Medicine - HSHS St. John's Children's Hospital
state: Illinois
city: South Bend
country: United States
facility: Memorial Hospital of South Bend
state: Indiana
city: Wichita
country: United States
facility: Wesley Medical Center
state: Kansas
city: Boston
country: United States
facility: Tufts Children's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Harvard Medical School - Beth Israel Deaconess Medical Center (Bidmc)
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: C.S Mott Children'S Hospital
state: Michigan
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Grand Rapids
country: United States
facility: Helen DeVos Children's Hospital Spectrum Health Research
state: Michigan
city: Minneapolis
country: United States
facility: Children'S Minnesota
state: Minnesota
city: Saint Paul
country: United States
facility: Associates in Newborn Medicine - Saint Paul
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Children'S Hospital At Montefiore
state: New York
city: Brooklyn
country: United States
facility: Kings County Hospital Center
state: New York
city: New Hyde Park
country: United States
facility: Cohen Children'S Medical Center of Ny
state: New York
city: New York
country: United States
facility: Northwell Health Cohen Children'S Medical Center of Ny
state: New York
city: Valhalla
country: United States
facility: Maria Fareri Children's Hospital - Westchester Medical Center
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Wilmington
country: United States
facility: New Hanover Regional Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Health Forest Baptist Health
state: North Carolina
city: Oklahoma City
country: United States
facility: Children'S Hospital At Ou Medicine
state: Oklahoma
city: Danville
country: United States
facility: Geisinger Health
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Jackson
country: United States
facility: Jackson Madison County General Hospital
state: Tennessee
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
city: Austin
country: United States
facility: St David'S Health Care - St. David'S Medical Center/North Austin Medical Center
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch - Ocr
state: Texas
city: Plano
country: United States
facility: Texas Health Presbyterian Hospital - Plano
state: Texas
city: Plano
country: United States
facility: Sheridan Healthcare of Texas, P.A./Medical City Plano
state: Texas
city: San Antonio
country: United States
facility: North Central Baptist Hospital
state: Texas
city: Richmond
country: United States
facility: Children's Hospital of Richmind at VCU
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University Medical Center
state: West Virginia
city: Pleven
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski" - Clinic of Neonatology
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda Hospital (Tokushukai Medical Corporation - Tokuda Hospital Sofia) (THS)
city: Sofia
country: Bulgaria
facility: Specialized Hospital in Active Treatment of Pediatric Diseases
city: Sofia
country: Bulgaria
facility: University Hospital of Obstetrics and Gynecology Maichin Dom - Neonatology Clinic
city: Amiens
country: France
facility: Chu Amiens-Picardie - Site Sud
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen Normandie
city: Colombes
country: France
facility: Hopital Louis Mourier
city: Debrecen
country: Hungary
facility: University of Debrecen Clinical Center
city: Kecskemét
country: Hungary
facility: Bács-Kiskun County Hospital
city: Miskolc
country: Hungary
facility: Borsod- Abaúj-Zemplén County Central Hospital and University Teaching Hospital
city: Nyiregyhaza
country: Hungary
facility: Szszb County Hospital and Jósa András University Teaching Hospital
city: Szeged
country: Hungary
facility: University of Szeged, Albert Szent-Györgyi Health Centre
city: Székesfehérvár
country: Hungary
facility: Szent György University Teaching Hospital of County Fejér
city: Veszprém
country: Hungary
facility: Veszprém County Csolnoky Ferenc Hospital
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Haifa
country: Israel
facility: Rambam Hospital
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
city: Szczecin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego im. prof. Tadeusza Sokołowskiego
city: Szczecin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 2 Pomorski Uniwersytet Medyczny (PUM) w Szczecinie /Pomeranian Medical University
city: Warsaw
country: Poland
facility: Uniwersyteckie Centrum Kliniczne, Warszawskiego Uniwersytetu Medycznego
city: Wrocław
country: Poland
facility: Uniwersytecki Szpital Kliniczny
city: Bukarest
country: Romania
facility: Spitalul Clinic de Obstetrica si Ginecologie "Filantropia"
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj-Napoca
city: Iaşi
country: Romania
facility: Spitalul Clinic de Obstetrica-Ginecologie "Cuza-Voda" Iasi
city: Timişoara
country: Romania
facility: Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timisoara
city: Timişoara
country: Romania
facility: Spitalul Clinic Municipal de Urgenta Timisoara
city: Kragujevac
country: Serbia
facility: Children's Clinic of the Clinical Center of Kragujevac
city: Alicante
country: Spain
facility: Hospital General de Alicante
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos - Idissc
city: Madrid
country: Spain
facility: Hospital Universitario Hm Puerta Del Sur
city: Tarragona
country: Spain
facility: Hospital Juan XXIII
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals, Neonatology: City Campus
Study officials:
affiliation: University of Florida College of Medicine, Gainsville, FL
name: Josef Neu, MD
role: PRINCIPAL_INVESTIGATOR
References: