IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Necrotizing Enterocolitis
In brief
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.
Key facts
- Study ID
- NCT03978000
- Run by
- Infant Bacterial Therapeutics
- People needed
- 2158
- Starts
- 2019-07-04
- Expected to finish
- 2024-07-01
- Last updated by the study team
- 2024-04-12
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- 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
- Sharp Memorial Hospital — San Diego, California, United States
- St. Francis Medical Center — Colorado Springs, Colorado, United States
- Connecticut Children'S Medical Center - Uconn - School of Medicine — Hartford, Connecticut, United States
- University of Florida Health — Gainesville, Florida, United States
- Wolfson Children'S Hospital — Jacksonville, Florida, United States
- Uf Health Jacksonville — Jacksonville, Florida, United States
- University of Miami/Holtz Children'S Hospital — Miami, Florida, United States
- Sheridan Clinical Research / Plantation General Hospital — Plantation, Florida, United States
- University of South Florida — Tampa, Florida, United States
- St. Joseph'S Women'S Hospital — Tampa, Florida, United States
- Georgia Regents University — Augusta, Georgia, United States
- Children'S Hospital of the University of Illinois — Chicago, Illinois, United States
- North Shore University Health System — Evanston, Illinois, United States
- SIU School of Medicine - HSHS St. John's Children's Hospital — Springfield, Illinois, 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
- Banner University Medical Center / University of Arizona — Tucson, Arizona, United States
Full record on ClinicalTrials.gov
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