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

Necrotizing Enterocolitis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03978000
• Other study ID #: IBP-9414-020
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 4, 2019
• Est. completion date: July 2024

Study information

• Verified date: April 2024
• Source: Infant Bacterial Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2158
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 48 Hours

Eligibility

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

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis

Intervention

Drug:
• IBP-9414
Oral suspension
• Placebo
Sterile water

Locations

Country	Name	City	State
Bulgaria	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
France	Chu Amiens-Picardie - Site Sud	Amiens
France	Centre Hospitalier Universitaire de Caen Normandie	Caen
France	Hopital Louis Mourier	Colombes
Hungary	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	Nyiregyhaza
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
Israel	Carmel Medical Center	Haifa
Israel	Rambam Hospital	Haifa
Israel	Tel-Aviv Sourasky Medical Center	Tel Aviv
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego im. prof. Tadeusza Sokolowskiego	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
Romania	Spitalul Clinic de Obstetrica si Ginecologie "Filantropia"	Bukarest
Romania	Spitalul Clinic Judetean de Urgenta Cluj-Napoca	Cluj-Napoca
Romania	Spitalul Clinic de Obstetrica-Ginecologie "Cuza-Voda" Iasi	Iasi
Romania	Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timisoara	Timisoara
Romania	Spitalul Clinic Municipal de Urgenta Timisoara	Timisoara
Serbia	Children's Clinic of the Clinical Center of Kragujevac	Kragujevac
Spain	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
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	Nottingham University Hospitals, Neonatology: City Campus	Nottingham
United States	C.S Mott Children'S Hospital	Ann Arbor	Michigan
United States	Georgia Regents University	Augusta	Georgia
United States	St David'S Health Care - St. David'S Medical Center/North Austin Medical Center	Austin	Texas
United States	Harvard Medical School - Beth Israel Deaconess Medical Center (Bidmc)	Boston	Massachusetts
United States	Tufts Children's Hospital	Boston	Massachusetts
United States	Children'S Hospital At Montefiore	Bronx	New York
United States	Kings County Hospital Center	Brooklyn	New York
United States	Medical University of South Carolina (MUSC)	Charleston	South Carolina
United States	Children'S Hospital of the University of Illinois	Chicago	Illinois
United States	St. Francis Medical Center	Colorado Springs	Colorado
United States	Geisinger Health	Danville	Pennsylvania
United States	Children's Hospital of Michigan	Detroit	Michigan
United States	Duke University	Durham	North Carolina
United States	North Shore University Health System	Evanston	Illinois
United States	University of Florida Health	Gainesville	Florida
United States	University of Texas Medical Branch - Ocr	Galveston	Texas
United States	Helen DeVos Children's Hospital Spectrum Health Research	Grand Rapids	Michigan
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Connecticut Children'S Medical Center - Uconn - School of Medicine	Hartford	Connecticut
United States	Jackson Madison County General Hospital	Jackson	Tennessee
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Uf Health Jacksonville	Jacksonville	Florida
United States	Wolfson Children'S Hospital	Jacksonville	Florida
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	University of Tennessee Health Science Center	Memphis	Tennessee
United States	University of Miami/Holtz Children'S Hospital	Miami	Florida
United States	Children'S Minnesota	Minneapolis	Minnesota
United States	West Virginia University Medical Center	Morgantown	West Virginia
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 Ou Medicine	Oklahoma City	Oklahoma
United States	Sheridan Healthcare of Texas, P.A./Medical City Plano	Plano	Texas
United States	Texas Health Presbyterian Hospital - Plano	Plano	Texas
United States	Sheridan Clinical Research / Plantation General Hospital	Plantation	Florida
United States	Children's Hospital of Richmind at VCU	Richmond	Virginia
United States	Associates in Newborn Medicine - Saint Paul	Saint Paul	Minnesota
United States	North Central Baptist Hospital	San Antonio	Texas
United States	Sharp Memorial Hospital	San Diego	California
United States	Memorial Hospital of South Bend	South Bend	Indiana
United States	Baystate Medical Center	Springfield	Massachusetts
United States	SIU School of Medicine - HSHS St. John's Children's Hospital	Springfield	Illinois
United States	St. Joseph'S Women'S Hospital	Tampa	Florida
United States	University of South Florida	Tampa	Florida
United States	Banner University Medical Center / University of Arizona	Tucson	Arizona
United States	Maria Fareri Children's Hospital - Westchester Medical Center	Valhalla	New York
United States	Wesley Medical Center	Wichita	Kansas
United States	New Hanover Regional Medical Center	Wilmington	North Carolina
United States	Wake Health Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Infant Bacterial Therapeutics

Countries where clinical trial is conducted

United States,  Bulgaria,  France,  Hungary,  Israel,  Poland,  Romania,  Serbia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed necrotizing enterocolitis (NEC)		From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Primary	Time to sustained feeding tolerance		From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Secondary	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
Secondary	Surgery (or autopsy) with confirmation of NEC		From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Secondary	Death all causes		From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Secondary	Number of days of hospitalization		From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Secondary	Weight gain in g/kg		Weeks 3 and 4 of age
Secondary	Number of subjects growing at =100 g/kg/week		Weeks 3 and 4 of age
Secondary	Days with clinical signs of feeding intolerance		From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age