Increasing the Yield of Blood Cultures in Neonates

Bacteremia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023555
• Other study ID #: SZMC-bromi
• Status: Completed
• Phase: N/A
• First received: December 1, 2009
• Last updated: July 24, 2011
• Start date: January 2010
• Est. completion date: July 2010

Study information

• Verified date: July 2011
• Source: Shaare Zedek Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bacteremia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non Inferiority of 1 cc blood culture in a single aerobic bottle instead of 0.5 cc for 2 bottles.		6months	No
Secondary	utility of the routine use of anaerobic bottle for blood cultures in newborns		6 months	No
Secondary	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	No