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.
Brief Title
IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study
Completion Date
Completion Date Type
Estimated
Conditions
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
* 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
Inclusion 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)
* 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)
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
48 Hours
NCT Id
NCT03978000
Org Class
Industry
Org Full Name
Infant Bacterial Therapeutics
Org Study Id
IBP-9414-020
Overall Status
Active, not recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
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
Primary Outcomes
Outcome Measure
Confirmed necrotizing enterocolitis (NEC)
Outcome Time Frame
From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Outcome Measure
Time to sustained feeding tolerance
Outcome Time Frame
From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Secondary Outcomes
Outcome Time Frame
From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Outcome 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.
Outcome Time Frame
From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Outcome Measure
Surgery (or autopsy) with confirmation of NEC
Outcome Time Frame
From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Outcome Measure
Death all causes
Outcome Time Frame
From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Outcome Measure
Number of days of hospitalization
Outcome Time Frame
Weeks 3 and 4 of age
Outcome Measure
Weight gain in g/kg
Outcome Time Frame
Weeks 3 and 4 of age
Outcome Measure
Number of subjects growing at ≥100 g/kg/week
Outcome Time Frame
From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Outcome Measure
Days with clinical signs of feeding intolerance
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Locked Fields
Render the field
Maximum Age Number (converted to Years and rounded down)
0
Minimum Age Number (converted to Years and rounded down)
0
Investigators
Investigator Type
Principal Investigator
Investigator Name
Shantanu Rastogi
Investigator Email
shrastogi@montefiore.org