IBP-9414 for the Prevention of Necrotizing Enterocolitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Necrotizing Enterocolitis

In brief

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

Key facts

Study ID

NCT02472769

Run by

Infant Bacterial Therapeutics

People needed

120

Starts

2016-05-27

Expected to finish

2017-08-07

Last updated by the study team

2017-12-29

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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