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

Infant Bacterial Therapeutics

Status and phase: Active, not recruiting; Phase 3

Conditions: Necrotizing Enterocolitis

Treatments: Drug: IBP-9414; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03978000

IBP-9414-020

Details and patient eligibility

About

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.

Enrollment: 2,158 patients

Sex: All

Ages: Under 48 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,158 participants in 2 patient groups, including a placebo group

IBP-9414

Active Comparator group

Treatment:

Drug: IBP-9414

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo