Clinical trial NCT02472769: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Necrotizing Enterocolitis
Lead sponsor: Infant Bacterial Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-06-16
Enrollment: 120
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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.

Primary outcomes:
measure: Safety and Tolerability of IBP-9414 as the observed number of adverse events (AE) and serious adverse events (SAE)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Univ. Arkansas Medical Sciences
state: Arkansas
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Gainesville
country: United States
facility: University Florida Health
state: Florida
city: Jacksonville
country: United States
facility: Wolfson Children´s Hospital
state: Florida
city: Jacksonville
country: United States
facility: UF Health Jacksonville
state: Florida
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: South Bend
country: United States
facility: Memorial Hospital of South Bend
state: Indiana
city: Wichita
country: United States
facility: Wesley Medical Center
state: Kansas
city: Brooklyn
country: United States
facility: Kings County Hospital Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Philadelphia
country: United States
facility: Hahnemann University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Einstein Medical Center of Philadelphia
state: Pennsylvania
city: Jackson
country: United States
facility: Jackson Madison County General Hospital
state: Tennessee
city: Orem
country: United States
facility: Timpanogos Regional Hospital
state: Utah
Study officials:
affiliation: University of Florida College of Medicine, Gainsville, FL
name: Josef Neu, MD
role: PRINCIPAL_INVESTIGATOR
References: