IBP-9414 for the Prevention of Necrotizing Enterocolitis
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.
1 other identifier
interventional
120
1 country
15
Brief Summary
Two different dose levels will be evaluated in two different birth weight categories, compared to placebo with regards to safety and tolerability.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2016
Shorter than P25 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2015
CompletedFirst Posted
Study publicly available on registry
June 16, 2015
CompletedStudy Start
First participant enrolled
May 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2017
CompletedDecember 29, 2017
January 1, 2017
1.2 years
June 2, 2015
December 28, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and Tolerability of IBP-9414 as the observed number of adverse events (AE) and serious adverse events (SAE)
12 months
Study Arms (2)
IBP-9414
ACTIVE COMPARATORIBP-9414 Oral Daily
Placebo
PLACEBO COMPARATORSterile water
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Univ. Arkansas Medical Sciences
Little Rock, Arkansas, 72202, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
University Florida Health
Gainesville, Florida, 32610-0296, United States
Wolfson Children´s Hospital
Jacksonville, Florida, 32207, United States
UF Health Jacksonville
Jacksonville, Florida, 32209, United States
Jackson Memorial Hospital
Miami, Florida, 33136, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Wesley Medical Center
Wichita, Kansas, 67214, United States
Kings County Hospital Center
Brooklyn, New York, 11203, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102, United States
Einstein Medical Center of Philadelphia
Philadelphia, Pennsylvania, 19141, United States
Jackson Madison County General Hospital
Jackson, Tennessee, 38301, United States
Timpanogos Regional Hospital
Orem, Utah, 84057, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Josef Neu, MD
University of Florida College of Medicine, Gainsville, FL
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2015
First Posted
June 16, 2015
Study Start
May 27, 2016
Primary Completion
August 7, 2017
Study Completion
August 7, 2017
Last Updated
December 29, 2017
Record last verified: 2017-01