IBP-9414 for the Prevention of Necrotizing Enterocolitis

Phase 2

Completed

• Conditions: Necrotizing Enterocolitis
• Interventions: Drug: IBP-9414; Drug: Placebo

• Registration Number: NCT02472769
• Lead Sponsor: Infant Bacterial Therapeutics

Brief Summary

Two different dose levels will be evaluated in two different birth weight categories, compared to placebo with regards to safety and tolerability.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-02
• Study First Submitted QC: 2015-06-11
• Study First Posted: 2015-06-16
• Study Start: 2016-05-27
• Status Verified: 2017-01
• Primary Completion: 2017-08-07
• Study Completion: 2017-08-07
• Last Update Submitted: 2017-12-28
• Last Update Posted: 2017-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Gestational age ≤32 weeks
2. Birth weight: a) ≤ 2,000 g and b) ≤ 1,000 g.
3. < 48 hours of age.
4. Written informed consent from the patient's legally authorized representative(s).

Exclusion Criteria

1. Participation in an additional interventional clinical trial in which an investigational drug will be administered.
2. Infants in extremis to whom no further intensive care is offered by attending neonatologist (e.g., infant being provided only hospice/comfort care).
3. Congenital or acquired gastrointestinal pathology.
4. Other conditions of the infant, which in the opinion of the attending neonatologist, preclude participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IBP-9414	IBP-9414	IBP-9414 Oral Daily
Placebo	Placebo	Sterile water

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of IBP-9414 as the observed number of adverse events (AE) and serious adverse events (SAE)	12 months

Trial Locations

Locations (15)

Univ. Arkansas Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

University Florida Health; 🇺🇸 Gainesville, Florida, United States

Wolfson Children´s Hospital; 🇺🇸 Jacksonville, Florida, United States

UF Health Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Jackson Memorial Hospital; 🇺🇸 Miami, Florida, United States

Memorial Hospital of South Bend; 🇺🇸 South Bend, Indiana, United States

Wesley Medical Center; 🇺🇸 Wichita, Kansas, United States

Kings County Hospital Center; 🇺🇸 Brooklyn, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

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