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

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

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