IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study

NCT03978000 · tracked via the Priya Life Science UK tracker

Sponsor

Infant Bacterial Therapeutics

Phase

Phase 3

Started

2019-07-04

Last updated

2024-04-12

Condition(s) studied

Necrotizing Enterocolitis

Investigational drug(s) / intervention(s)

IBP-9414Placebo

IBP-9414: Oral suspension

Placebo: Sterile water

Study summary

IBP-9414 will be evaluated in preterm infants with a birth weight of 500-1500g, compared to placebo with regards to efficacy and safety in the prevention of necrotizing enterocolitis.

Eligibility

Sex

ALL

Min age

—

Max age

48 Hours

Healthy volunteers

Inclusion Criteria: * Gestational age at birth of 23 weeks+0 days to 32 weeks+0 days * Birth weight 500-1500g * ≤ 48 hours of age * Written informed consent from the subject´s legally authorized representative (LAR) Exclusion Criteria: * Participation in any other interventional clinical trial * Infants in extremis to whom no further intensive care is offered by attending neonatologist * Infants with, or at a high probability for, early onset sepsis * Infants with recognized chromosomal anomalies * Congenital or acquired gastrointestinal disease * Earlier or planned administration of formulas, foods or supplements that contain added live bacteria * Infants with known positive maternal HIV status

Primary outcome measure(s)

Confirmed necrotizing enterocolitis (NEC) — From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Time to sustained feeding tolerance — From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age

Trial sites (89)

Facility	City	Region
Banner University Medical Center / University of Arizona	Tucson	Arizona
Arkansas Children'S Hospital	Little Rock	Arkansas
University of Arkansas For Medical Services	Little Rock	Arkansas
Loma Linda University Children Hospital	Loma Linda	California
Good Samaritan Hospital	Los Angeles	California
LAC & USC Medical Center	Los Angeles	California
University of Califorina, Los Angeles (UCLA)	Los Angeles	California
Valley Childrens Hospital	Madera	California
Sharp Memorial Hospital	San Diego	California
St. Francis Medical Center	Colorado Springs	Colorado
Connecticut Children'S Medical Center - Uconn - School of Medicine	Hartford	Connecticut
University of Florida Health	Gainesville	Florida
Wolfson Children'S Hospital	Jacksonville	Florida
Uf Health Jacksonville	Jacksonville	Florida
University of Miami/Holtz Children'S Hospital	Miami	Florida
Sheridan Clinical Research / Plantation General Hospital	Plantation	Florida
University of South Florida	Tampa	Florida
St. Joseph'S Women'S Hospital	Tampa	Florida
Georgia Regents University	Augusta	Georgia
Children'S Hospital of the University of Illinois	Chicago	Illinois
North Shore University Health System	Evanston	Illinois
SIU School of Medicine - HSHS St. John's Children's Hospital	Springfield	Illinois
Memorial Hospital of South Bend	South Bend	Indiana
Wesley Medical Center	Wichita	Kansas
Tufts Children's Hospital	Boston	Massachusetts
Harvard Medical School - Beth Israel Deaconess Medical Center (Bidmc)	Boston	Massachusetts
Baystate Medical Center	Springfield	Massachusetts
C.S Mott Children'S Hospital	Ann Arbor	Michigan
Children's Hospital of Michigan	Detroit	Michigan
Helen DeVos Children's Hospital Spectrum Health Research	Grand Rapids	Michigan
Children'S Minnesota	Minneapolis	Minnesota
Associates in Newborn Medicine - Saint Paul	Saint Paul	Minnesota
University of Mississippi Medical Center	Jackson	Mississippi
Hackensack University Medical Center	Hackensack	New Jersey
Kings County Hospital Center	Brooklyn	New York
Cohen Children'S Medical Center of Ny	New Hyde Park	New York
Northwell Health Cohen Children'S Medical Center of Ny	New York	New York
Children'S Hospital At Montefiore	The Bronx	New York
Maria Fareri Children's Hospital - Westchester Medical Center	Valhalla	New York
Duke University	Durham	North Carolina

+ 49 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03978000 on ClinicalTrials.gov ↗ ← All trials in the UK