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

Phase 3Active Not RecruitingNCT03978000

Infant Bacterial Therapeutics2,158 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

2,158

Conditions

Necrotizing Enterocolitis

Interventions

Oral suspension

Sterile water

Eligibility

Sex: ALLMax age: 48 Hours

Medical Language ↔ Plain English

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

Locations (89)

Outcomes

Primary Outcomes

Confirmed necrotizing enterocolitis (NEC)

Time frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age

Time to sustained feeding tolerance

Time frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age

Secondary Outcomes

At least one clinical sign of NEC as reported by the investigator AND abdominal X-ray evidence of intestinal pneumatosis and/or portal venous gas confirmed by independent adjudication.

Time frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age

Surgery (or autopsy) with confirmation of NEC

Time frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age

Death all causes

Time frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age

Number of days of hospitalization

Time frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age

Weight gain in g/kg

Time frame: Weeks 3 and 4 of age

Number of subjects growing at ≥100 g/kg/week

Time frame: Weeks 3 and 4 of age

Days with clinical signs of feeding intolerance

Time frame: From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age

Data from ClinicalTrials.gov

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NCT03978000 - IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study | Crick | Crick