Increasing the Yield of Blood Cultures in Neonates

July 24, 2011 updated by: Shaare Zedek Medical Center

Increasing the Yield of Blood Cultures in the Neonatal Intensive Care Unit- A Prospective Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1500

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Non Inferiority of 1 cc blood culture in a single aerobic bottle instead of 0.5 cc for 2 bottles.
Time Frame: 6months
6months

Secondary Outcome Measures

Outcome Measure
Time Frame
utility of the routine use of anaerobic bottle for blood cultures in newborns
Time Frame: 6 months
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaare Zedek Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

December 1, 2009

First Submitted That Met QC Criteria

December 1, 2009

First Posted (Estimate)

December 2, 2009

Study Record Updates

Last Update Posted (Estimate)

July 26, 2011

Last Update Submitted That Met QC Criteria

July 24, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SZMC-bromi

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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