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Finding Ideal Blood Culture Volume in NICU

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ClinicalTrials.gov Identifier: NCT02468947
Recruitment Status : Unknown
Verified August 2016 by Bromiker, Ruben M.D, Shaare Zedek Medical Center.
Recruitment status was:  Recruiting
First Posted : June 11, 2015
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
Bromiker, Ruben M.D, Shaare Zedek Medical Center

Brief Summary:
The investigators want to assess the effectivity of different sample volumes in blood cultures.

Condition or disease
Ideal Sample Volume for Blood Cultures

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.

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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Finding Ideal Blood Culture Volume in NICU
Study Start Date : April 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017



Primary Outcome Measures :
  1. Positive blood cultures of each group [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Time to positivity for each group [ Time Frame: 2 years ]
  2. Suspected contamination rate [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All babies treated in the neonatology department of the institution undergoing sepsis workup
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468947


Locations
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Israel
Ruben Bromiker Recruiting
Jerusalem, Israel, 91031
Contact: Ruben Bromiker, MD    972508685154    bromi@smc.org.il   
Contact: Yair Kasirer, MD    972586476885    yairkasirer@yahoo.com   
Sponsors and Collaborators
Shaare Zedek Medical Center
Publications of Results:
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Responsible Party: Bromiker, Ruben M.D, Senior Physician NICU, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02468947    
Other Study ID Numbers: 182/14
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016
Keywords provided by Bromiker, Ruben M.D, Shaare Zedek Medical Center:
Neonatal sepsis