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Increasing the Yield of Blood Cultures in Neonates

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ClinicalTrials.gov Identifier: NCT01023555
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : July 26, 2011
Sponsor:
Information provided by:
Shaare Zedek Medical Center

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.

Condition or disease Intervention/treatment Phase
Bacteremia Other: 1cc of blood in a single aerobic culture bottle Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Increasing the Yield of Blood Cultures in the Neonatal Intensive Care Unit- A Prospective Controlled Trial
Study Start Date : January 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Arm Intervention/treatment
No Intervention: 0.5cc 2 Bottles
Active Comparator: 1cc single bottle Other: 1cc of blood in a single aerobic culture bottle
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 Measures :
  1. 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 Measures :
  1. utility of the routine use of anaerobic bottle for blood cultures in newborns [ Time Frame: 6 months ]
  2. 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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ruben Bromiker MD, Shaare Zedec Medical Center
ClinicalTrials.gov Identifier: NCT01023555     History of Changes
Other Study ID Numbers: SZMC-bromi
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: July 2011
Keywords provided by Shaare Zedek Medical Center:
Bacteremia
Blood Cultures
Sepsis
Additional relevant MeSH terms:
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Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes