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

Primary Purpose

Necrotizing Enterocolitis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
IBP-9414
Placebo
Sponsored by
Infant Bacterial Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Necrotizing Enterocolitis

Eligibility Criteria

undefined - 48 Hours (Child)All SexesDoes not accept 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

Sites / Locations

  • Banner University Medical Center / University of ArizonaRecruiting
  • Arkansas Children'S HospitalRecruiting
  • University of Arkansas For Medical ServicesRecruiting
  • Loma Linda University Children HospitalRecruiting
  • Good Samaritan HospitalRecruiting
  • LAC & USC Medical CenterRecruiting
  • University of Califorina, Los Angeles (UCLA)Recruiting
  • Valley Childrens HospitalRecruiting
  • Sharp Memorial HospitalRecruiting
  • St. Francis Medical CenterRecruiting
  • Connecticut Children'S Medical Center - Uconn - School of MedicineRecruiting
  • University of Florida HealthRecruiting
  • Wolfson Children'S HospitalRecruiting
  • Uf Health JacksonvilleRecruiting
  • University of Miami/Holtz Children'S HospitalRecruiting
  • Sheridan Clinical Research / Plantation General Hospital
  • University of South FloridaRecruiting
  • St. Joseph'S Women'S HospitalRecruiting
  • Georgia Regents UniversityRecruiting
  • Children'S Hospital of the University of IllinoisRecruiting
  • North Shore University Health SystemRecruiting
  • SIU School of Medicine - HSHS St. John's Children's HospitalRecruiting
  • Memorial Hospital of South BendRecruiting
  • Wesley Medical CenterRecruiting
  • Tufts Children's HospitalRecruiting
  • Harvard Medical School - Beth Israel Deaconess Medical Center (Bidmc)Recruiting
  • Baystate Medical CenterRecruiting
  • C.S Mott Children'S HospitalRecruiting
  • Children's Hospital of MichiganRecruiting
  • Helen DeVos Children's Hospital Spectrum Health ResearchRecruiting
  • Children'S MinnesotaRecruiting
  • Associates in Newborn Medicine - Saint PaulRecruiting
  • University of Mississippi Medical CenterRecruiting
  • Hackensack University Medical CenterRecruiting
  • Children'S Hospital At MontefioreRecruiting
  • Kings County Hospital CenterRecruiting
  • Cohen Children'S Medical Center of NyRecruiting
  • Northwell Health Cohen Children'S Medical Center of NyRecruiting
  • Maria Fareri Children's Hospital - Westchester Medical CenterRecruiting
  • Duke UniversityRecruiting
  • New Hanover Regional Medical CenterRecruiting
  • Wake Health Forest Baptist HealthRecruiting
  • Children'S Hospital At Ou MedicineRecruiting
  • Geisinger HealthRecruiting
  • Medical University of South Carolina (MUSC)Recruiting
  • Jackson Madison County General HospitalRecruiting
  • University of Tennessee Health Science CenterRecruiting
  • St David'S Health Care - St. David'S Medical Center/North Austin Medical CenterRecruiting
  • University of Texas Medical Branch - OcrRecruiting
  • Texas Health Presbyterian Hospital - PlanoRecruiting
  • Sheridan Healthcare of Texas, P.A./Medical City PlanoRecruiting
  • North Central Baptist HospitalRecruiting
  • Children's Hospital of Richmind at VCURecruiting
  • West Virginia University Medical CenterRecruiting
  • University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski" - Clinic of NeonatologyRecruiting
  • University Multiprofile Hospital for Active TreatmentRecruiting
  • Acibadem City Clinic Tokuda Hospital (Tokushukai Medical Corporation - Tokuda Hospital Sofia) (THS)Recruiting
  • Specialized Hospital in Active Treatment of Pediatric DiseasesRecruiting
  • University Hospital of Obstetrics and Gynecology Maichin Dom - Neonatology ClinicRecruiting
  • Chu Amiens-Picardie - Site SudRecruiting
  • Centre Hospitalier Universitaire de Caen NormandieRecruiting
  • Hopital Louis MourierRecruiting
  • University of Debrecen Clinical CenterRecruiting
  • Bács-Kiskun County HospitalRecruiting
  • Borsod- Abaúj-Zemplén County Central Hospital and University Teaching HospitalRecruiting
  • Szszb County Hospital and Jósa András University Teaching HospitalRecruiting
  • University of Pécs Faculty of Medicine
  • University of Szeged, Albert Szent-Györgyi Health CentreRecruiting
  • Szent György University Teaching Hospital of County FejérRecruiting
  • Veszprém County Csolnoky Ferenc HospitalRecruiting
  • Carmel Medical CenterRecruiting
  • Rambam HospitalRecruiting
  • Tel-Aviv Sourasky Medical CenterRecruiting
  • Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego im. prof. Tadeusza SokołowskiegoRecruiting
  • Samodzielny Publiczny Szpital Kliniczny nr 2 Pomorski Uniwersytet Medyczny (PUM) w Szczecinie /Pomeranian Medical UniversityRecruiting
  • Uniwersyteckie Centrum Kliniczne, Warszawskiego Uniwersytetu MedycznegoRecruiting
  • Uniwersytecki Szpital KlinicznyRecruiting
  • Spitalul Clinic de Obstetrica si Ginecologie "Filantropia"Recruiting
  • Spitalul Clinic Judetean de Urgenta Cluj-NapocaRecruiting
  • Spitalul Clinic de Obstetrica-Ginecologie "Cuza-Voda" IasiRecruiting
  • Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" TimisoaraRecruiting
  • Spitalul Clinic Municipal de Urgenta TimisoaraRecruiting
  • Children's Clinic of the Clinical Center of KragujevacRecruiting
  • Hospital General de AlicanteRecruiting
  • Hospital Clinico San Carlos - IdisscRecruiting
  • Hospital Universitario Hm Puerta Del SurRecruiting
  • Hospital Universitario La Paz
  • Hospital Juan XXIIIRecruiting
  • Hospital Universitario La FeRecruiting
  • Nottingham University Hospitals NHS TrustRecruiting
  • Nottingham University Hospitals, Neonatology: City CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

IBP-9414

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Confirmed necrotizing enterocolitis (NEC)
Time to sustained feeding tolerance

Secondary Outcome Measures

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.
Surgery (or autopsy) with confirmation of NEC
Death all causes
Number of days of hospitalization
Weight gain in g/kg
Number of subjects growing at ≥100 g/kg/week
Days with clinical signs of feeding intolerance

Full Information

First Posted
June 5, 2019
Last Updated
March 8, 2022
Sponsor
Infant Bacterial Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03978000
Brief Title
IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 4, 2019 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Infant Bacterial Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotizing Enterocolitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IBP-9414
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
IBP-9414
Intervention Description
Oral suspension
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sterile water
Primary Outcome Measure Information:
Title
Confirmed necrotizing enterocolitis (NEC)
Time Frame
From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Title
Time to sustained feeding tolerance
Time Frame
From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Secondary Outcome Measure Information:
Title
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.
Time Frame
From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Title
Surgery (or autopsy) with confirmation of NEC
Time Frame
From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Title
Death all causes
Time Frame
From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Title
Number of days of hospitalization
Time Frame
From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age
Title
Weight gain in g/kg
Time Frame
Weeks 3 and 4 of age
Title
Number of subjects growing at ≥100 g/kg/week
Time Frame
Weeks 3 and 4 of age
Title
Days with clinical signs of feeding intolerance
Time Frame
From the first dose until the infant reaches 34 weeks + 6 days post-menstrual age

10. Eligibility

Sex
All
Maximum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anders Kronström
Phone
+46841014555
Email
clinical@ibtherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josef Neu, MD
Organizational Affiliation
University of Florida College of Medicine, Gainsville, FL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner University Medical Center / University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ranjit Kylathu, MD
Facility Name
Arkansas Children'S Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vikas Chowdhary, MD
Phone
501-364-1100
Facility Name
University of Arkansas For Medical Services
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vikas Chowdhary, MD
Phone
479-713-8000
Facility Name
Loma Linda University Children Hospital
City
Loma Linda
State/Province
California
ZIP/Postal Code
11234
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elba Fayard, MD
Phone
909-558-8000
Facility Name
Good Samaritan Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rangasamy Ramanathan, MD
Phone
213-977-2121
Facility Name
LAC & USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manoj Biniwale, MD
Phone
323-409-1000
Facility Name
University of Califorina, Los Angeles (UCLA)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meena Garg, MD
Phone
310-825-4321
Facility Name
Valley Childrens Hospital
City
Madera
State/Province
California
ZIP/Postal Code
93636
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Indira Chandrasekar, MD
Phone
559-353-3000
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anup Katheria, MD
Phone
858-939-3400
Facility Name
St. Francis Medical Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80923
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allen Wu, MD
Phone
719-571-1000
Facility Name
Connecticut Children'S Medical Center - Uconn - School of Medicine
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Wolkoff, MD
Phone
860-545-9000
Facility Name
University of Florida Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josef Neu, MD
Phone
352-392-1161
Facility Name
Wolfson Children'S Hospital
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Hudak, MD
Phone
904-202-8000
Facility Name
Uf Health Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Hudak, MD
Phone
904-244-0411
Facility Name
University of Miami/Holtz Children'S Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Teresa Del-Moral, MD
Phone
305-585-5437
Facility Name
Sheridan Clinical Research / Plantation General Hospital
City
Plantation
State/Province
Florida
ZIP/Postal Code
33323
Country
United States
Individual Site Status
Terminated
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime Flores-Torres, MD
Phone
813-974-2011
Facility Name
St. Joseph'S Women'S Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenelle Ferry, MD
Phone
813-879-4730
Facility Name
Georgia Regents University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quyen Pham, MD
Phone
706-721-0211
Facility Name
Children'S Hospital of the University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
De-Ann Pillers, MD
Phone
866-600-2273
Facility Name
North Shore University Health System
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandy Frost, MD
Phone
847-677-1750
Facility Name
SIU School of Medicine - HSHS St. John's Children's Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62769
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beau Batton, MD
Phone
217-535-3699
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert White, MD
Phone
574-647-1000
Facility Name
Wesley Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barry Bloom, MD
Phone
316-962-2000
Facility Name
Tufts Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachana Singh, MD
Phone
617-636-8100
Facility Name
Harvard Medical School - Beth Israel Deaconess Medical Center (Bidmc)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Frantz, MD
Phone
617-667-7000
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Rothstein, MD
Phone
413-794-0000
Facility Name
C.S Mott Children'S Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsay Ellsworth, MD
Phone
734-936-4000
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Lua, MD
Phone
313-745-5437
Facility Name
Helen DeVos Children's Hospital Spectrum Health Research
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benedict Doctor, MD
Phone
866-989-7999
First Name & Middle Initial & Last Name & Degree
Amy Pribyl
Email
Amy.Pribyl@spectrumhealth.org
Facility Name
Children'S Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Lampland, MD
Phone
612-813-6000
Facility Name
Associates in Newborn Medicine - Saint Paul
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Lampland, MD
Phone
651-220-6260
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mobolaji Famuyide, MD
Phone
601-984-1000
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Spillane, MD
Phone
551-996-2000
Facility Name
Children'S Hospital At Montefiore
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Havranek, MD
Phone
718-741-2426
Facility Name
Kings County Hospital Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Hand, MD
Phone
718-245-3131
Facility Name
Cohen Children'S Medical Center of Ny
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahana Perveen, MD
Phone
718-470-3000
Facility Name
Northwell Health Cohen Children'S Medical Center of Ny
City
New York
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahana Perveen, MD
Phone
718-470-3000
Facility Name
Maria Fareri Children's Hospital - Westchester Medical Center
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lance Parton, MD
Phone
914-493-7552
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Ashley, MD
Phone
919-684-8111
Facility Name
New Hanover Regional Medical Center
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Moya, MD
Phone
910-667-7000
Facility Name
Wake Health Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Porcelli, MD
Phone
336-716-2011
Facility Name
Children'S Hospital At Ou Medicine
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hala Chaaban, MD
Phone
405-271-4700
Facility Name
Geisinger Health
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ray Hayes, MD
Phone
570-207-5337
Facility Name
Medical University of South Carolina (MUSC)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carol Wagner, MD
Phone
843-792-1414
Facility Name
Jackson Madison County General Hospital
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Guthrie, MD
Phone
731-541-5000
Facility Name
University of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ajay Talati, MD
Phone
901-448-5000
Facility Name
St David'S Health Care - St. David'S Medical Center/North Austin Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Rudine, MD
Phone
512-901-1000
Facility Name
University of Texas Medical Branch - Ocr
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael Fonseca, MD
Phone
409-772-2222
Facility Name
Texas Health Presbyterian Hospital - Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Santiago, MD
Phone
972-981-8000
Facility Name
Sheridan Healthcare of Texas, P.A./Medical City Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75075-6199
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keyaria Gray, MD
Phone
972-596-6800
Facility Name
North Central Baptist Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaashif Ahmad, MD
Phone
210-297-4000
Facility Name
Children's Hospital of Richmind at VCU
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Russel Moores, MD
Phone
804-828-2467
Facility Name
West Virginia University Medical Center
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Polak, MD
Phone
304-264-1000
Facility Name
University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski" - Clinic of Neonatology
City
Pleven
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Atanasova, MD
Phone
+35964886100
Facility Name
University Multiprofile Hospital for Active Treatment
City
Plovdiv
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Argirova, MD
Phone
+359887344330
Facility Name
Acibadem City Clinic Tokuda Hospital (Tokushukai Medical Corporation - Tokuda Hospital Sofia) (THS)
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Radka Maslarska, MD
Phone
+35924034000
Facility Name
Specialized Hospital in Active Treatment of Pediatric Diseases
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralitsa Georgieva, MD
Phone
+35928154211
Facility Name
University Hospital of Obstetrics and Gynecology Maichin Dom - Neonatology Clinic
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boriana Slancheva, MD
Phone
+35929172200
Facility Name
Chu Amiens-Picardie - Site Sud
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andre Léké, MD
Phone
+33322088000
Facility Name
Centre Hospitalier Universitaire de Caen Normandie
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Fazilleau, MD
Phone
+33231063106
Facility Name
Hopital Louis Mourier
City
Colombes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc Desfrere, MD
Phone
+33147606162
Facility Name
University of Debrecen Clinical Center
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Nagy, MD
Phone
+3652411717
Facility Name
Bács-Kiskun County Hospital
City
Kecskemét
ZIP/Postal Code
6000
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gyula Talosi, MD
Phone
+3678564001
Facility Name
Borsod- Abaúj-Zemplén County Central Hospital and University Teaching Hospital
City
Miskolc
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ildiko Szucs, MD
Phone
+3646515200
Facility Name
Szszb County Hospital and Jósa András University Teaching Hospital
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ferenc Dicso, MD
Phone
+3642599700
Facility Name
University of Pécs Faculty of Medicine
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
University of Szeged, Albert Szent-Györgyi Health Centre
City
Szeged
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Csaba Bereczki, MD
Phone
+3662545331
Facility Name
Szent György University Teaching Hospital of County Fejér
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zoltán Kummer, MD
Phone
+3622535500
Facility Name
Veszprém County Csolnoky Ferenc Hospital
City
Veszprém
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Szabo, MD
Phone
+3688556000
Facility Name
Carmel Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michal Molad, MD
Phone
+97248250211
Facility Name
Rambam Hospital
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ori Hochwald, MD
Phone
+97247772222
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronella Marom, MD
Phone
+97236974444
Facility Name
Samodzielny Publiczny Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego im. prof. Tadeusza Sokołowskiego
City
Szczecin
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnieszka Kordek, MD
Phone
+48914253000
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 2 Pomorski Uniwersytet Medyczny (PUM) w Szczecinie /Pomeranian Medical University
City
Szczecin
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beata Loniewska, MD
Phone
+48914661000
Facility Name
Uniwersyteckie Centrum Kliniczne, Warszawskiego Uniwersytetu Medycznego
City
Warsaw
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnieszka Kociszewska-Najman, MD
Phone
+48223179165
Facility Name
Uniwersytecki Szpital Kliniczny
City
Wrocław
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Krolak-Olejnik, MD
Phone
+48717331110
Facility Name
Spitalul Clinic de Obstetrica si Ginecologie "Filantropia"
City
Bukarest
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mihaela Demetrian, MD
Phone
+40213188930
Facility Name
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
City
Cluj-Napoca
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriela Zaharie, MD
Phone
+40264597852
Facility Name
Spitalul Clinic de Obstetrica-Ginecologie "Cuza-Voda" Iasi
City
Iaşi
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Stamatin, MD
Phone
+40232213000
Facility Name
Spitalul Clinic de Urgenta pentru Copii "Louis Turcanu" Timisoara
City
Timişoara
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marioara Boia, MD
Phone
+40256203303
Facility Name
Spitalul Clinic Municipal de Urgenta Timisoara
City
Timişoara
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriela Olariu, MD
Phone
+40256433530
Facility Name
Children's Clinic of the Clinical Center of Kragujevac
City
Kragujevac
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dragana Ristic, MD
Phone
+38134505050
Facility Name
Hospital General de Alicante
City
Alicante
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caridad Tapia, MD
Phone
+34965933000
Facility Name
Hospital Clinico San Carlos - Idissc
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrique Criado, MD
Phone
+34913303793
Facility Name
Hospital Universitario Hm Puerta Del Sur
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerardo Romera, MD
Phone
+34901088212
Facility Name
Hospital Universitario La Paz
City
Madrid
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Hospital Juan XXIII
City
Tarragona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M.Mar Albujar Font, MD
Phone
+34977295800
Facility Name
Hospital Universitario La Fe
City
Valencia
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maximo Vento Torres, MD
Phone
+34961244000
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Don Sharkey, MD
Facility Name
Nottingham University Hospitals, Neonatology: City Campus
City
Nottingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dushyant Batra, MD
Phone
+44 115 924 9924

12. IPD Sharing Statement

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

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