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

Purpose

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.

Condition

  • Necrotizing Enterocolitis

Eligibility

Eligible Ages
Under 48 Hours
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
IBP-9414
  • Drug: IBP-9414
    Oral suspension
Placebo Comparator
Placebo
  • Drug: Placebo
    Sterile water

More Details

Status
Active, not recruiting
Sponsor
Infant Bacterial Therapeutics

Study Contact