Finding Ideal Blood Culture Volume in NICU | NCT02468947

Studies
Finding Ideal Blood Culture Volume in NICU

NCT02468947

Sponsor

Shaare Zedek Medical Center

Status

Unknown status

Last Update Posted

Aug 9, 2016Estimated

Enrollment

800Estimated

Phase

Not provided

Conditions

Ideal Sample Volume for Blood Cultures

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Jun 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Jun 9, 2015

First Submission Date that Met QC Criteria

Jun 10, 2015

First Posted Date

Jun 11, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2016

Last Update Posted Date

Aug 9, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bromiker, Ruben M.D, Senior Physician NICU, Shaare Zedek Medical CenterPrincipal Investigator

Lead Sponsor

Shaare Zedek Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators want to assess the effectivity of different sample volumes in 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

800Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Positive blood cultures of each group		2 years

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ruben Bromiker	Recruiting	Jerusalem		91031	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25764096	Result	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.

ID	Term
D018805	Sepsis
D007239	Infections
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities