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Clinical Outcome of Neonates With GBS Positive Culture-12 Year Retrospective Study

Primary Purpose

Infants With Positive GBS Bacteremia

Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Infants With Positive GBS Bacteremia focused on measuring Group B streptococci, virulent, morbidity, mortality

Eligibility Criteria

0 Years - 2 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: GBS positive blood culture neonate and preterm babies Exclusion Criteria: Congenital malformations

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 14, 2006
    Last Updated
    May 15, 2006
    Sponsor
    Sheba Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00326313
    Brief Title
    Clinical Outcome of Neonates With GBS Positive Culture-12 Year Retrospective Study
    Official Title
    Clinical Outcome of Neonate With GBS Positive Culture-12 Year Retrospective Study
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    May 2006
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sheba Medical Center

    4. Oversight

    5. Study Description

    Brief Summary
    Streptococci group B (GBS) is a the major reason for morbidity and mortality in neonates. It can present as pneumonia ,meningitis or sepsis.The mortality today is 5-20% and even more in preterm babies. During the past two decade, the introduction of protocols for prophylactic antibiotics for women with a high risk for GBS infection, have led to a decline of 65% in GBS cases(0.32 for 1000 live birth compared to 1.8 cases in 1000).The purpose of the study is to check the morbidity and mortality at Sheba medical center in the last 12 years in children with positive blood culture for GBS. We assume that in our hospital the morbidity and mortality is less then expected. If proven right, we would then check the reasons for that outcome considering the type and length of treatment and the different virulence of the streptococcus.
    Detailed Description
    This is a retrospective case control study. We will review from archive the charts of all the neonates with positive blood culture for GBS, reviewing the course and severity of their illness.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infants With Positive GBS Bacteremia
    Keywords
    Group B streptococci, virulent, morbidity, mortality

    7. Study Design

    Enrollment
    74 (false)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    0 Years
    Maximum Age & Unit of Time
    2 Weeks
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: GBS positive blood culture neonate and preterm babies Exclusion Criteria: Congenital malformations
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tzipora Strauss, MD
    Organizational Affiliation
    Sheba Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Outcome of Neonates With GBS Positive Culture-12 Year Retrospective Study

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