Increasing the Yield of Blood Cultures in Neonates
1 other identifier
interventional
1,500
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2010
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2009
CompletedFirst Posted
Study publicly available on registry
December 2, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedJuly 26, 2011
July 1, 2011
6 months
December 1, 2009
July 24, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Non Inferiority of 1 cc blood culture in a single aerobic bottle instead of 0.5 cc for 2 bottles.
6months
Secondary Outcomes (2)
utility of the routine use of anaerobic bottle for blood cultures in newborns
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)
6 months
Study Arms (2)
0.5cc 2 Bottles
NO INTERVENTION1cc single bottle
ACTIVE COMPARATORInterventions
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
Eligibility Criteria
You may qualify if:
- All blood cultures taken in the NICU during the study period.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 25764096DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 1, 2009
First Posted
December 2, 2009
Study Start
January 1, 2010
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
July 26, 2011
Record last verified: 2011-07