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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBP-9414 | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBP-9414 | Drug | Oral suspension |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josef Neu, MD | University of Florida College of Medicine, Gainsville, FL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center / University of Arizona | Tucson | Arizona | 85724 | United States | ||
| Arkansas Children'S Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40348496 | Derived | Frazer LC, Orgel KA, Good M. Dysbiotic Microbiota in Necrotizing Enterocolitis: Insights into Pathogenesis, Treatment, and Prevention. Gastroenterol Clin North Am. 2025 Jun;54(2):415-427. doi: 10.1016/j.gtc.2024.11.001. Epub 2025 Jan 24. |
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| Drug |
Sterile water |
|
| 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 |
| Number of subjects growing at ≥100 g/kg/week | Weeks 3 and 4 of age |
| Days with clinical signs of feeding intolerance | From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| University of Arkansas For Medical Services | Little Rock | Arkansas | 72205 | United States |
| Loma Linda University Children Hospital | Loma Linda | California | 11234 | United States |
| Good Samaritan Hospital | Los Angeles | California | 90017 | United States |
| LAC & USC Medical Center | Los Angeles | California | 90033 | United States |
| University of Califorina, Los Angeles (UCLA) | Los Angeles | California | 90095 | United States |
| Valley Childrens Hospital | Madera | California | 93636 | United States |
| Sharp Memorial Hospital | San Diego | California | 92123 | United States |
| St. Francis Medical Center | Colorado Springs | Colorado | 80923 | United States |
| Connecticut Children'S Medical Center - Uconn - School of Medicine | Hartford | Connecticut | 06106 | United States |
| University of Florida Health | Gainesville | Florida | 32610 | United States |
| Wolfson Children'S Hospital | Jacksonville | Florida | 32207 | United States |
| Uf Health Jacksonville | Jacksonville | Florida | 32209 | United States |
| University of Miami/Holtz Children'S Hospital | Miami | Florida | 33136 | United States |
| Sheridan Clinical Research / Plantation General Hospital | Plantation | Florida | 33323 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| St. Joseph'S Women'S Hospital | Tampa | Florida | 33607 | United States |
| Georgia Regents University | Augusta | Georgia | 30912 | United States |
| Children'S Hospital of the University of Illinois | Chicago | Illinois | 60612 | United States |
| North Shore University Health System | Evanston | Illinois | 60201 | United States |
| SIU School of Medicine - HSHS St. John's Children's Hospital | Springfield | Illinois | 62769 | United States |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | United States |
| Wesley Medical Center | Wichita | Kansas | 67214 | United States |
| Tufts Children's Hospital | Boston | Massachusetts | 02111 | United States |
| Harvard Medical School - Beth Israel Deaconess Medical Center (Bidmc) | Boston | Massachusetts | 02215 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| C.S Mott Children'S Hospital | Ann Arbor | Michigan | 48109 | United States |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | United States |
| Helen DeVos Children's Hospital Spectrum Health Research | Grand Rapids | Michigan | 49503 | United States |
| Children'S Minnesota | Minneapolis | Minnesota | 55404 | United States |
| Associates in Newborn Medicine - Saint Paul | Saint Paul | Minnesota | 55102 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Kings County Hospital Center | Brooklyn | New York | 11203 | United States |
| Cohen Children'S Medical Center of Ny | New Hyde Park | New York | 11040 | United States |
| Northwell Health Cohen Children'S Medical Center of Ny | New York | New York | 11040 | United States |
| Children'S Hospital At Montefiore | The Bronx | New York | 10461 | United States |
| Maria Fareri Children's Hospital - Westchester Medical Center | Valhalla | New York | 10595 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| New Hanover Regional Medical Center | Wilmington | North Carolina | 28401 | United States |
| Wake Health Forest Baptist Health | Winston-Salem | North Carolina | 27012 | United States |
| Children'S Hospital At Ou Medicine | Oklahoma City | Oklahoma | 73104 | United States |
| Geisinger Health | Danville | Pennsylvania | 17822 | United States |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | United States |
| Jackson Madison County General Hospital | Jackson | Tennessee | 38301 | United States |
| University of Tennessee Health Science Center | Memphis | Tennessee | 38163 | United States |
| St David'S Health Care - St. David'S Medical Center/North Austin Medical Center | Austin | Texas | 78705 | United States |
| University of Texas Medical Branch - Ocr | Galveston | Texas | 77555 | United States |
| Texas Health Presbyterian Hospital - Plano | Plano | Texas | 75024 | United States |
| Sheridan Healthcare of Texas, P.A./Medical City Plano | Plano | Texas | 75075-6199 | United States |
| North Central Baptist Hospital | San Antonio | Texas | 78258 | United States |
| Children's Hospital of Richmind at VCU | Richmond | Virginia | 23298 | United States |
| West Virginia University Medical Center | Morgantown | West Virginia | 26506 | 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 | 4032 | Hungary |
| Bács-Kiskun County Hospital | Kecskemét | 6000 | Hungary |
| Borsod- Abaúj-Zemplén County Central Hospital and University Teaching Hospital | Miskolc | Hungary |
| Szszb County Hospital and Jósa András University Teaching Hospital | Nyíregyháza | 4400 | Hungary |
| University of Szeged, Albert Szent-Györgyi Health Centre | Szeged | Hungary |
| Szent György University Teaching Hospital of County Fejér | Székesfehérvár | 8000 | 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 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 11, 2026 | Jun 5, 2026 | 7 |
| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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