IBP-9414 for Necrotizing Enterocolitis

Recruiting at 90 trial locations

Overseen by Josef Neu, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Infant Bacterial Therapeutics

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing IBP-9414 to see if it can prevent a serious gut disease in premature babies who weigh between 500 and 1500 grams. The treatment likely helps keep their intestines healthy and reduces infections.

Research Team

Josef Neu, MD

Principal Investigator

University of Florida College of Medicine, Gainsville, FL

Eligibility Criteria

This trial is for preterm infants born between 23 and 32 weeks of gestation, weighing 500-1500g, and under 48 hours old. Infants with chromosomal anomalies, enrolled in other trials, critically ill without intensive care options, at high risk for early sepsis, with gastrointestinal diseases or exposed to HIV are excluded.

Inclusion Criteria

Gestational age at birth of 23 weeks+0 days to 32 weeks+0 days

≤ 48 hours of age

Written informed consent from the subject´s legally authorized representative (LAR)

Exclusion Criteria

Infants with recognized chromosomal anomalies

Participation in any other interventional clinical trial

Infants in extremis to whom no further intensive care is offered by attending neonatologist

Treatment Details

Interventions

• IBP-9414 (Protein)

Trial Overview The study tests IBP-9414's effectiveness and safety in preventing necrotizing enterocolitis (a serious intestinal disease) in preterm infants compared to a placebo. The goal is to see if this treatment can protect these vulnerable babies from developing the condition.

Participant Groups

Group I: IBP-9414 Active Control 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Infant Bacterial Therapeutics

Lead Sponsor

Trials

2

Recruited

2,300+