Finding Ideal Blood Culture Volume in NICU

August 7, 2016 updated by: Bromiker, Ruben M.D, Shaare Zedek Medical Center
The investigators want to assess the effectivity of different sample volumes in blood cultures.

Study Overview

Status

Unknown

Conditions

Detailed Description

The investigators intend to compare yield of 0.5ml sample x2 vs 0.25 ml samples x2 (aerobic and anaerobic media for each volume) taken from the sample taken from the same site and time.

Time to positivity will also be compared, as well as possible contamination rates.

Study Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91031
        • Recruiting
        • Ruben Bromiker
        • Contact:
        • Contact:

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

Sampling Method

Probability Sample

Study Population

All babies treated in the neonatology department of the institution undergoing sepsis workup

Description

Inclusion Criteria:

  • Suspected sepsis

Exclusion Criteria:

  • Need for extra puncture in order to withdraw enough blood for the second set of cultures.
  • Urgent need for antibiotic without time for cultures.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Positive blood cultures of each group
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to positivity for each group
Time Frame: 2 years
2 years
Suspected contamination rate
Time Frame: 2 years
2 years

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

April 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

June 9, 2015

First Submitted That Met QC Criteria

June 10, 2015

First Posted (Estimate)

June 11, 2015

Study Record Updates

Last Update Posted (Estimate)

August 9, 2016

Last Update Submitted That Met QC Criteria

August 7, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 182/14

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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