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Protein

IBP-9414 for Necrotizing Enterocolitis

Phase 3
Waitlist Available
Led By Josef Neu, MD
Research Sponsored by Infant Bacterial Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Awards & highlights

Study Summary

This trial will test a new medication to see if it can prevent a disease called necrotizing enterocolitis in premature babies.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects of IBP-9414 aren't listed here, common concerns may include reactions at the administration site, digestive issues or imbalances in gut bacteria due to its nature as an intestinal-focused treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the first dose until the infant reaches 34 weeks + 6 days post-menstrual age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Confirmed necrotizing enterocolitis (NEC)
Time to sustained feeding tolerance
Secondary outcome measures
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.
Days with clinical signs of feeding intolerance
Death all causes
+4 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: IBP-9414Active Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Infant Bacterial TherapeuticsLead Sponsor
1 Previous Clinical Trials
120 Total Patients Enrolled
Josef Neu, MDPrincipal InvestigatorUniversity of Florida College of Medicine, Gainsville, FL
4 Previous Clinical Trials
369 Total Patients Enrolled

Media Library

IBP-9414 (Protein) Clinical Trial Eligibility Overview. Trial Name: NCT03978000 — Phase 3
Necrotizing Enterocolitis Research Study Groups: Placebo, IBP-9414
Necrotizing Enterocolitis Clinical Trial 2023: IBP-9414 Highlights & Side Effects. Trial Name: NCT03978000 — Phase 3
IBP-9414 (Protein) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03978000 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project being conducted across different states?

"Enrolment for this trial is taking place at 55 sites, with locations in Wilmington, Chicago, Grand Rapids, and other cities. If you're looking to enroll, try to select the location nearest to you to limit travel."

Answered by AI

What are the deleterious effects of IBP-9414?

"IBP-9414 Phase 3 trial data looks promising and there is robust safety data, so it received a score of 3."

Answered by AI

Are new participants being allowed to sign up for this experiment?

"That is correct. The study, which was first advertised on July 4th, 2019, is still looking for participants. The 55 different enrolment sites are recruiting a total of 2158 patients."

Answered by AI

How many people are included in the trial?

"In order to fulfil the requirements of this trial, 2158 patients must be recruited. The patients can come from different medical centres, such as New Hanvover Regional Medical Center in Wilmington, North carolina and Children'S Hospital of the University of Illinois in Chicago, Illinois."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Texas Health Presbyterian Hospital - Plano
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study
2019. "IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03978000.
All > Colitis
~0 spots leftby Jun 2024
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