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Clinical Trials in Spain / NCT03978000
Active, not recruiting Phase 3

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

NCT03978000 · tracked via the Priya Life Science Spain 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
No
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)

FacilityCityRegionStatus
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 Spain