๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2024-04-11

IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study (NCT03978000)

A Randomized, Double Blind, Parallel-group, Placebo Controlled Study to Evaluate the Efficacy and Safety of IBP-9414 in Premature Infants 500-1500g Birth Weight in the Prevention of Necrotizing Enterocolitis - The Connection Study

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Infant Bacterial Therapeutics

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Banner University Medical Center / University of Arizona โ€” Tucson, Arizona

Age range: Not specified to 48 Hours

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (89 Sites)

Showing the first 25 of 89 sites.

  • Banner University Medical Center / University of Arizona โ€” Tucson, Arizona
  • Arkansas Children'S Hospital โ€” Little Rock, Arkansas
  • University of Arkansas For Medical Services โ€” Little Rock, Arkansas
  • Loma Linda University Children Hospital โ€” Loma Linda, California
  • Good Samaritan Hospital โ€” Los Angeles, California
  • LAC & USC Medical Center โ€” Los Angeles, California
  • University of Califorina, Los Angeles (UCLA) โ€” Los Angeles, California
  • Valley Childrens Hospital โ€” Madera, California
  • Sharp Memorial Hospital โ€” San Diego, California
  • St. Francis Medical Center โ€” Colorado Springs, Colorado
  • Connecticut Children'S Medical Center - Uconn - School of Medicine โ€” Hartford, Connecticut
  • University of Florida Health โ€” Gainesville, Florida
  • Wolfson Children'S Hospital โ€” Jacksonville, Florida
  • Uf Health Jacksonville โ€” Jacksonville, Florida
  • University of Miami/Holtz Children'S Hospital โ€” Miami, Florida
  • Sheridan Clinical Research / Plantation General Hospital โ€” Plantation, Florida
  • University of South Florida โ€” Tampa, Florida
  • St. Joseph'S Women'S Hospital โ€” Tampa, Florida
  • Georgia Regents University โ€” Augusta, Georgia
  • Children'S Hospital of the University of Illinois โ€” Chicago, Illinois
  • North Shore University Health System โ€” Evanston, Illinois
  • SIU School of Medicine - HSHS St. John's Children's Hospital โ€” Springfield, Illinois
  • Memorial Hospital of South Bend โ€” South Bend, Indiana
  • Wesley Medical Center โ€” Wichita, Kansas
  • Tufts Children's Hospital โ€” Boston, Massachusetts

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—