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Increasing the Yield of Blood Cultures in Neonates

Primary Purpose

Bacteremia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
1cc of blood in a single aerobic culture bottle
Sponsored by
Shaare Zedek Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bacteremia focused on measuring Bacteremia, Blood Cultures, Sepsis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All blood cultures taken in the NICU during the study period.

Exclusion Criteria:

  • Bacteria that are normal flora of the skin such as Coagulase negative staphylococci or Streptococci Viridans are considered, except if grown in two sets of cultures or in the presence of laboratory and clinical indices of infection.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    0.5cc 2 Bottles

    1cc single bottle

    Arm Description

    Outcomes

    Primary Outcome Measures

    Non Inferiority of 1 cc blood culture in a single aerobic bottle instead of 0.5 cc for 2 bottles.

    Secondary Outcome Measures

    utility of the routine use of anaerobic bottle for blood cultures in newborns
    Comparison of time to positivity of 1 cc blood culture in a single aerobic bottle instead of 0.5 cc for 2 bottles (aerobic and anaerobic)

    Full Information

    First Posted
    December 1, 2009
    Last Updated
    July 24, 2011
    Sponsor
    Shaare Zedek Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01023555
    Brief Title
    Increasing the Yield of Blood Cultures in Neonates
    Official Title
    Increasing the Yield of Blood Cultures in the Neonatal Intensive Care Unit- A Prospective Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    July 2010 (Actual)
    Study Completion Date
    July 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Shaare Zedek Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether the use of a single blood sample of 1cc in an aerobic bottle will provide a better yield and time to positivity than 2 samples of 0.5 cc in 2 (aerobic and anaerobic) bottles for blood cultures in neonates.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bacteremia
    Keywords
    Bacteremia, Blood Cultures, Sepsis

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    1500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    0.5cc 2 Bottles
    Arm Type
    No Intervention
    Arm Title
    1cc single bottle
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    1cc of blood in a single aerobic culture bottle
    Intervention Description
    The efficacy of using 1cc of blood in a single aerobic bottle for cultures in neonatal bacteremia will will be compared with the traditional 0.5cc of blood in 2 Bottles
    Primary Outcome Measure Information:
    Title
    Non Inferiority of 1 cc blood culture in a single aerobic bottle instead of 0.5 cc for 2 bottles.
    Time Frame
    6months
    Secondary Outcome Measure Information:
    Title
    utility of the routine use of anaerobic bottle for blood cultures in newborns
    Time Frame
    6 months
    Title
    Comparison of time to positivity of 1 cc blood culture in a single aerobic bottle instead of 0.5 cc for 2 bottles (aerobic and anaerobic)
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All blood cultures taken in the NICU during the study period. Exclusion Criteria: Bacteria that are normal flora of the skin such as Coagulase negative staphylococci or Streptococci Viridans are considered, except if grown in two sets of cultures or in the presence of laboratory and clinical indices of infection.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25764096
    Citation
    Yaacobi N, Bar-Meir M, Shchors I, Bromiker R. A prospective controlled trial of the optimal volume for neonatal blood cultures. Pediatr Infect Dis J. 2015 Apr;34(4):351-4. doi: 10.1097/INF.0000000000000594.
    Results Reference
    derived

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    Increasing the Yield of Blood Cultures in Neonates

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