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

Phase 3
Active, not recruiting
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
IBP-9414IBP-9414-
PlaceboPlacebo-
Primary Outcome Measures
NameTimeMethod
Confirmed necrotizing enterocolitis (NEC)From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Time to sustained feeding toleranceFrom the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Secondary Outcome Measures
NameTimeMethod
Surgery (or autopsy) with confirmation of NECFrom the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Number of days of hospitalizationFrom 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 causesFrom the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Days with clinical signs of feeding intoleranceFrom the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Weight gain in g/kgWeeks 3 and 4 of age
Number of subjects growing at ≥100 g/kg/weekWeeks 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

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