Skip to main content
Update Location

My Location

Update your location to show providers, locations, and services closest to you.

Enter a zip code
Or
Select a campus/region
(352) 733-0111

Probiotic Study

  • Status
    Accepting Candidates
  • Age
    N/A - 48 Hours
  • Sexes
    All
  • Healthy Volunteers
    No
I'm interested
Share this study
Facebook
Twitter
LinkedIn

Objective

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.

Details

Full study 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
Protocol number OCR29602
ClinicalTrials.gov ID NCT03978000
Phase Phase 3

Eligibility

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

Lead researcher

  • Josef Neu, MD
    Neonatal-Perinatal Specialist
    Languages: German
    Josef Neu

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

    Josef Neu
  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.