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

• Status: Recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Infant Bacterial Therapeutics

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