The Volume of Blood Submitted for Culture in Neonates - a Multicentre Quality Improvement Initiative. (VOB4C)

June 30, 2022 updated by: PAWEL KRAJEWSKI, MD, Medical University of Warsaw

The Volume of Blood Submitted for Culture in Neonates - a Multicentre Initiative to Improve the Value of the Test by Bedside Weighing of Blood Samples.

The study will examine if introducing the practice of checking the volume of blood culture samples in neonates by bedside weighing will improve the sensitivity of the test and increase confidence in negative results affecting the rate of extended antibiotic treatment in neonates with negative blood cultures.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In the first part of the study (pre-intervention) the actual volumes of blood submitted for culture in neonates from participating neonatal units will be examined for the period of six months. The culture vials will be pre-weighted using precision scale before delivery to the units. After collecting the sample the vials will be weighted again at the time of admission to microbiology laboratory. At the end of the first phase, the results will be revealed to clinical teams and discussed. The sample volume control by using bedside precision scale will be introduced to the participating units along with educational actions to raise the awareness of importance of collecting adequate volume of blood for culture. The minimum volume of blood will be defined as at minimum 1 ml. The paramount role of blood culture in process of ruling out newborn sepsis will be emphasized. In the second phase of the study clinicians in participating centres will have an opportunity of measuring the volume of samples just after collecting. The volumes will also be independently controlled in the microbiology laboratory. The second phase will also last six months. Collected volumes will be compared to results from pre-intervention period. Clinical outcome measured by frequency of antibiotic treatment in newborn patients with negative blood culture will be compared before and after implemented changes. We hypothesize that introducing routine bedside control of the blood volume submitted for culture will result in increase confidence in negative blood culture results and decrease of antibiotic use in newborn population.

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Tomasz Wawrzoniak, MD
  • Phone Number: +48 225830336
  • Email: wawrzon@mp.pl

Study Locations

  • Poland
      • Warsaw, Poland
        • Recruiting
        • Department of Neonatology, Orlowski Public Teaching Hospital, Centre of Medical Postgraduate Education
        • Contact:
        • Principal Investigator:
          • Tomasz Wawrzoniak
      • Warsaw, Poland
        • Recruiting
        • Neonatal Unit, Holy Family Hospital
        • Contact:
      • Warsaw, Poland
        • Recruiting
        • Specialistic Hospital 'Inflancka'
        • Contact:
    • Warszawa
      • Warsaw, Warszawa, Poland, 02-015
        • Withdrawn
        • Division of Neonatology and Neonatal Intensive Care, 1st Department of Obstetrics and Gynaecology, The Medical University of Warsaw

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

No older than 4 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All infants cared for in neonatal wards with suspected bacterial sepsis who have blood culture collected. All infants from birth to discharge will be considered eligible for the study.

Description

Inclusion Criteria:

- Any infant in a neonatal ward who has a blood culture collected (either early-onset or late-onset sepsis suspected).

Exclusion Criteria:

- There is no exclusion criteria.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Any infant who will have a blood culture collected.
During the study period educational actions will be taken to raise the awareness of importance of collecting adequate volume of blood for culture (posters, leaflets and educational activities). The minimum volume will be defined as at least 1 ml. The paramount role of blood culture in process of ruling out newborn sepsis will be emphasized. The sample volume control by using bedside precision scale will be introduced.
Other: Bedside blood culture bottles weighing combined with educational interventions.
Educational actions will be taken to raise the awareness of importance of collecting adequate volume of blood for culture (posters, leaflets and educational activities). The minimum volume will be defined as at least 1 ml. The paramount role of blood culture in process of ruling out newborn sepsis will be emphasized. The sample volume control by using bedside precision scale will be introduced.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The volume of blood submitted for culture.
Time Frame: Through study completion, an average of 1 year.
The volume of blood submitted for culture will be determined by weighing blood culture bottle before and after blood inoculation. The percentage of adequately filled blood culture bottles, i.e. at least 1 ml, will be compared between each study period.
Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The use of systemic antibiotics.
Time Frame: Through study completion, an average of 1 year.
The use of antibiotic therapy >72 hours despite negative blood culture results. The percentage of patients treated with antibiotics >72 hours despite negative blood cultures will be compared between each study period.
Through study completion, an average of 1 year.
Blood culture false-positive rate (contamination rate).
Time Frame: Through study completion, an average of 1 year.
The rate of blood culture contamination will be calculated by dividing the number of contaminated blood cultures by the total number of blood cultures collected during the study period.
Through study completion, an average of 1 year.
Blood culture true-positive rate.
Time Frame: Through study completion, an average of 1 year.
The rate of true positive blood cultures will be calculated by dividing the number of blood cultures that yield a pathogenic microorganism by the total number of blood cultures collected during the study period.
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Principal Investigator: Pawel Krajewski, MD, PhD, Medical University of Warsaw

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 (Actual)

May 10, 2022

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 8, 2023

Study Registration Dates

First Submitted

June 22, 2020

First Submitted That Met QC Criteria

June 29, 2020

First Posted (Actual)

July 2, 2020

Study Record Updates

Last Update Posted (Actual)

July 5, 2022

Last Update Submitted That Met QC Criteria

June 30, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VOB4C TRIAL'20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial will be available, after deidentification. The study protocol will also be available. These documents will be accessible to anyone who provides a methodologically sound proposal immediately following publication with no end date.

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing Access Criteria

Anyone who provides a methodologically sound proposal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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