IBP-9414 for the Prevention of Necrotizing Enterocolitis
NCT ID: NCT02472769
Last Updated: 2017-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2016-05-27
2017-08-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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IBP-9414
IBP-9414 Oral Daily
IBP-9414
Placebo
Sterile water
Placebo
Sterile water
Interventions
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IBP-9414
Placebo
Sterile water
Eligibility Criteria
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Inclusion Criteria
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
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.
48 Hours
ALL
No
Sponsors
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Infant Bacterial Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Josef Neu, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida College of Medicine, Gainsville, FL
Locations
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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
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States
Einstein Medical Center of Philadelphia
Philadelphia, Pennsylvania, United States
Jackson Madison County General Hospital
Jackson, Tennessee, United States
Timpanogos Regional Hospital
Orem, Utah, United States
Countries
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Other Identifiers
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IBP-9414-010
Identifier Type: -
Identifier Source: org_study_id