Open Actively Recruiting

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

About

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.

Primary Purpose
Prevention
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
N/A
Maximum Age
48 Hours

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

Join this Trial

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Study Stats
Protocol No.
18-001826
Category
Pediatrics
Principal Investigator
Contact
Ruby Escalante
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT03978000
For detailed technical eligibility, visit ClinicalTrials.gov.