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

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

Sponsors

Lead Sponsor: Infant Bacterial Therapeutics

Source Infant Bacterial Therapeutics
Brief 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.

Overall Status Recruiting
Start Date July 4, 2019
Completion Date December 2021
Primary Completion Date November 2021
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Secondary Outcome
Measure Time Frame
At least one clinical sign of NEC as reported by the investigator AND abdominal X-ray evidence of intestinal pneumatosis and/or portal venous gas confirmed by independent adjudication. From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Surgery (or autopsy) with confirmation of NEC From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Death all causes From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Number of days of hospitalization From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Weight gain in g/kg Weeks 3 and 4 of age
Number of subjects growing at ≥100 g/kg/week Weeks 3 and 4 of age
Days with clinical signs of feeding intolerance From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Enrollment 2158
Condition
Intervention

Intervention Type: Drug

Intervention Name: IBP-9414

Description: Oral suspension

Arm Group Label: IBP-9414

Intervention Type: Drug

Intervention Name: Placebo

Description: Sterile water

Arm Group Label: Placebo

Eligibility

Criteria:

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

Gender: All

Minimum Age: N/A

Maximum Age: 48 Hours

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Josef Neu, MD Principal Investigator University of Florida College of Medicine, Gainsville, FL
Overall Contact

Last Name: Anders Kronstrom

Phone: +46841014555

Email: [email protected]

Location
Facility: Status: Contact:
Arkansas Children'S Hospital | Little Rock, Arkansas, 72205, United States Recruiting BLAIR SUZAN [email protected]
University of Arkansas For Medical Services | Little Rock, Arkansas, 72205, United States Recruiting Sherry Courtney, MD [email protected]
Loma Linda University Children Hospital | Loma Linda, California, 11234, United States Recruiting Lila Dalton [email protected]
University of Califorina, Los Angeles (UCLA) | Los Angeles, California, 90095, United States Recruiting ALEJANDRA GUZMAN [email protected]
Connecticut Children'S Medical Center - Uconn - School of Medicine | Hartford, Connecticut, 06106, United States Recruiting KRISTEN GRANDONICO [email protected]
Wolfson Children'S Hospital | Jacksonville, Florida, 32207, United States Recruiting Kim Barnette [email protected]
Uf Health Jacksonville | Jacksonville, Florida, 32209, United States Recruiting Shelly Crawford [email protected]
University of Miami/Holtz Children'S Hospital | Miami, Florida, 33136, United States Recruiting SILVIA MARTINEZ [email protected]
Sheridan Clinical Research / Plantation General Hospital | Plantation, Florida, 33323, United States Terminated
University of South Florida | Tampa, Florida, 33606, United States Recruiting Marcia Kneusel [email protected]
St. Joseph'S Women'S Hospital | Tampa, Florida, 33607, United States Recruiting VICTORIA FRANCO 813-872-2929
Children'S Hospital of the University of Illinois | Chicago, Illinois, 60612, United States Recruiting DE-ANN PILLERS [email protected]
North Shore University Health System | Evanston, Illinois, 60201, United States Recruiting ILENE WOLF [email protected]
Memorial Hospital of South Bend | South Bend, Indiana, 46601, United States Recruiting Jane Kaiser [email protected]
Wesley Medical Center | Wichita, Kansas, 67214, United States Recruiting Paula Delmore [email protected]
Harvard Medical School - Beth Israel Deaconess Medical Center (Bidmc) | Boston, Massachusetts, 02215, United States Recruiting NEHA THAKKAR [email protected]
Baystate Medical Center | Springfield, Massachusetts, 01199, United States Recruiting Lori-Ann Kozikowski [email protected]
C.S Mott Children'S Hospital | Ann Arbor, Michigan, 48109, United States Recruiting DIANE WHITE [email protected]
Children'S Minnesota | Minneapolis, Minnesota, 55404, United States Recruiting MOLLY FISHER [email protected]
Associates in Newborn Medicine - Saint Paul | Saint Paul, Minnesota, 55102, United States Recruiting CATHY WORWA [email protected]
University of Mississippi Medical Center | Jackson, Mississippi, 39216, United States Recruiting Carly Tuura [email protected]
Children'S Hospital At Montefiore | Bronx, New York, 10461, United States Recruiting THOMAS HAVRANEK, MD [email protected]
Cohen Children'S Medical Center of Ny | New Hyde Park, New York, 11040, United States Recruiting DEBRA POTAK [email protected]
Northwell Health Cohen Children'S Medical Center of Ny | New York, New York, 11040, United States Recruiting DEBRA POTAK [email protected]
Duke University | Durham, North Carolina, 27705, United States Recruiting GRACE JEFFERSON [email protected]
Children'S Hospital At Ou Medicine | Oklahoma City, Oklahoma, 73104, United States Recruiting ROBERT WELLIVER [email protected]
Jackson Madison County General Hospital | Jackson, Tennessee, 38301, United States Recruiting Scott Guthrie, MD [email protected]
University of Tennessee Health Science Center | Memphis, Tennessee, 38163, United States Recruiting GAIL CAMP [email protected]
St David'S Health Care - St. David'S Medical Center/North Austin Medical Center | Austin, Texas, 78705, United States Recruiting MATT COWPERTHWAITE [email protected]
University of Texas Medical Branch - Ocr | Galveston, Texas, 77555, United States Recruiting MARIANNE SHAFER [email protected]
Sheridan Healthcare of Texas, P.A./Medical City Plano | Plano, Texas, 75075-6199, United States Recruiting COURTNEY SAENZ [email protected]
West Virginia University Medical Center | Morgantown, West Virginia, 26506, United States Recruiting MARK POLAK, MD [email protected]
Chu Amiens-Picardie - Site Sud | Amiens, France Recruiting ESTELLE JOSSE [email protected]
Hopital Louis Mourier | Colombes, France Recruiting LUC DESFRERE, MD [email protected]
University of Debrecen Clinical Center | Debrecen, 4032, Hungary Recruiting Andrea Nagy, MD [email protected]
Bács-Kiskun County Hospital | Kecskemét, 6000, Hungary Recruiting Gyula Talosi, MD [email protected]
Borsod- Abaúj-Zemplén County Central Hospital and University Teaching Hospital | Miskolc, Hungary Recruiting ILDIKO SZUCS, MD [email protected]
Szszb County Hospital and Jósa András University Teaching Hospital | Nyiregyhaza, 4400, Hungary Recruiting Ferenc Dicso, MD [email protected]
University of Pécs Faculty of Medicine | Pécs, 7624, Hungary Recruiting Tibor Ertl, MD [email protected]te.hu
Szent György University Teaching Hospital of County Fejér | Székesfehérvár, 8000, Hungary Recruiting Helga Toth-Bencze [email protected]
Veszprém County Csolnoky Ferenc Hospital | Veszprém, Hungary Recruiting EVA SZABO, MD [email protected]
Hospital General de Alicante | Alicante, Spain Recruiting Caridad Tapia [email protected]
Hospital Clinico San Carlos - Idissc | Madrid, Spain Recruiting Francisco Perez [email protected]
Hospital Universitario Hm Puerta Del Sur | Madrid, Spain Recruiting Lorena Sanchez [email protected]
Hospital Universitario La Paz | Madrid, Spain Withdrawn
Hospital Universitario La Fe | Valencia, Spain Recruiting JUAN MARTINEZ RODILLA [email protected]
Location Countries

France

Hungary

Spain

United States

Verification Date

May 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: IBP-9414

Type: Active Comparator

Label: Placebo

Type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov