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NCT02472769 Clinical Trial

IBP-9414 for the Prevention of Necrotizing Enterocolitis

Necrotizing Enterocolitis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02472769
Other study ID # IBP-9414-010
Secondary ID
Status Completed
Phase Phase 2
First received June 2, 2015
Last updated December 28, 2017
Start date May 27, 2016
Est. completion date August 7, 2017

Study information
Verified date January 2017
Source Infant Bacterial Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date August 7, 2017
Est. primary completion date August 7, 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 48 Hours
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• IBP-9414

• Placebo
Sterile water

Locations
Country Name City State
United States Kings County Hospital Center Brooklyn New York
United States Duke University Medical Center Durham North Carolina
United States University Florida Health Gainesville Florida
United States Jackson Madison County General Hospital Jackson Tennessee
United States UF Health Jacksonville Jacksonville Florida
United States Wolfson Children´s Hospital Jacksonville Florida
United States Univ. Arkansas Medical Sciences Little Rock Arkansas
United States UCLA Medical Center Los Angeles California
United States Jackson Memorial Hospital Miami Florida
United States Timpanogos Regional Hospital Orem Utah
United States Einstein Medical Center of Philadelphia Philadelphia Pennsylvania
United States Hahnemann University Hospital Philadelphia Pennsylvania
United States Memorial Hospital of South Bend South Bend Indiana
United States Wesley Medical Center Wichita Kansas
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Infant Bacterial Therapeutics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and Tolerability of IBP-9414 as the observed number of adverse events (AE) and serious adverse events (SAE) 12 months
See also
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