Back to resultsIBP-9414 for the Prevention of Necrotizing Enterocolitis
Primary Purpose
Necrotizing Enterocolitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IBP-9414
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Necrotizing Enterocolitis
Eligibility Criteria
Inclusion Criteria:
- Gestational age ≤32 weeks
- Birth weight: a) ≤ 2,000 g and b) ≤ 1,000 g.
- < 48 hours of age.
- Written informed consent from the patient's legally authorized representative(s).
Exclusion Criteria:
- Participation in an additional interventional clinical trial in which an investigational drug will be administered.
- Infants in extremis to whom no further intensive care is offered by attending neonatologist (e.g., infant being provided only hospice/comfort care).
- Congenital or acquired gastrointestinal pathology.
- Other conditions of the infant, which in the opinion of the attending neonatologist, preclude participation.
Sites / Locations
- Univ. Arkansas Medical Sciences
- UCLA Medical Center
- University Florida Health
- Wolfson Children´s Hospital
- UF Health Jacksonville
- Jackson Memorial Hospital
- Memorial Hospital of South Bend
- Wesley Medical Center
- Kings County Hospital Center
- Duke University Medical Center
- Wake Forest University Health Sciences
- Hahnemann University Hospital
- Einstein Medical Center of Philadelphia
- Jackson Madison County General Hospital
- Timpanogos Regional Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
IBP-9414
Placebo
Arm Description
IBP-9414 Oral Daily
Sterile water
Outcomes
Primary Outcome Measures
Safety and Tolerability of IBP-9414 as the observed number of adverse events (AE) and serious adverse events (SAE)
Secondary Outcome Measures
Full Information
NCT ID
NCT02472769
First Posted
June 2, 2015
Last Updated
December 28, 2017
Sponsor
Infant Bacterial Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT02472769
Brief Title
IBP-9414 for the Prevention of Necrotizing Enterocolitis
Official Title
A Randomized, Double Blind, Parallel-group, Dose Escalation Placebo-controlled Multicenter Study to Investigate the Safety and Tolerability of IBP-9414 Administered in Preterm Infants.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 27, 2016 (Actual)
Primary Completion Date
August 7, 2017 (Actual)
Study Completion Date
August 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Infant Bacterial Therapeutics
4. Oversight
5. Study Description
Brief Summary
Two different dose levels will be evaluated in two different birth weight categories, compared to placebo with regards to safety and tolerability.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotizing Enterocolitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IBP-9414
Arm Type
Active Comparator
Arm Description
IBP-9414 Oral Daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sterile water
Intervention Type
Drug
Intervention Name(s)
IBP-9414
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sterile water
Primary Outcome Measure Information:
Title
Safety and Tolerability of IBP-9414 as the observed number of adverse events (AE) and serious adverse events (SAE)
Time Frame
12 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gestational age ≤32 weeks
Birth weight: a) ≤ 2,000 g and b) ≤ 1,000 g.
< 48 hours of age.
Written informed consent from the patient's legally authorized representative(s).
Exclusion Criteria:
Participation in an additional interventional clinical trial in which an investigational drug will be administered.
Infants in extremis to whom no further intensive care is offered by attending neonatologist (e.g., infant being provided only hospice/comfort care).
Congenital or acquired gastrointestinal pathology.
Other conditions of the infant, which in the opinion of the attending neonatologist, preclude participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josef Neu, MD
Organizational Affiliation
University of Florida College of Medicine, Gainsville, FL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univ. Arkansas Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University Florida Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0296
Country
United States
Facility Name
Wolfson Children´s Hospital
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
UF Health Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Wesley Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Kings County Hospital Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Hahnemann University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Einstein Medical Center of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Jackson Madison County General Hospital
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
Timpanogos Regional Hospital
City
Orem
State/Province
Utah
ZIP/Postal Code
84057
Country
United States
12. IPD Sharing Statement
Learn more about this trial
IBP-9414 for the Prevention of Necrotizing Enterocolitis
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