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)
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
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
Scroll for more (79 remaining)Banner University Medical Center / University of Arizona🇺🇸Tucson, Arizona, United States