<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04455022</url>
  </required_header>
  <id_info>
    <org_study_id>VOB4C TRIAL'20</org_study_id>
    <nct_id>NCT04455022</nct_id>
  </id_info>
  <brief_title>The Volume of Blood Submitted for Culture in Neonates - a Multicentre Quality Improvement Initiative.</brief_title>
  <acronym>VOB4C</acronym>
  <official_title>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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Warsaw</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Warsaw</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will examine if introducing the practice of checking the volume of blood culture&#xD;
      samples in neonates by bedside weighing will improve the sensitivity of the test and increase&#xD;
      confidence in negative results affecting the rate of extended antibiotic treatment in&#xD;
      neonates with negative blood cultures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the first part of the study (pre-intervention) the actual volumes of blood submitted for&#xD;
      culture in neonates from participating neonatal units will be examined for the period of six&#xD;
      months. The culture vials will be pre-weighted using precision scale before delivery to the&#xD;
      units. After collecting the sample the vials will be weighted again at the time of admission&#xD;
      to microbiology laboratory. At the end of the first phase, the results will be revealed to&#xD;
      clinical teams and discussed. The sample volume control by using bedside precision scale will&#xD;
      be introduced to the participating units along with educational actions to raise the&#xD;
      awareness of importance of collecting adequate volume of blood for culture. The minimum&#xD;
      volume of blood will be defined as at minimum 1 ml. The paramount role of blood culture in&#xD;
      process of ruling out newborn sepsis will be emphasized. In the second phase of the study&#xD;
      clinicians in participating centres will have an opportunity of measuring the volume of&#xD;
      samples just after collecting. The volumes will also be independently controlled in the&#xD;
      microbiology laboratory. The second phase will also last six months. Collected volumes will&#xD;
      be compared to results from pre-intervention period. Clinical outcome measured by frequency&#xD;
      of antibiotic treatment in newborn patients with negative blood culture will be compared&#xD;
      before and after implemented changes. We hypothesize that introducing routine bedside control&#xD;
      of the blood volume submitted for culture will result in increase confidence in negative&#xD;
      blood culture results and decrease of antibiotic use in newborn population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 10, 2022</start_date>
  <completion_date type="Anticipated">July 8, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The volume of blood submitted for culture.</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The use of systemic antibiotics.</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>The use of antibiotic therapy &gt;72 hours despite negative blood culture results. The percentage of patients treated with antibiotics &gt;72 hours despite negative blood cultures will be compared between each study period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood culture false-positive rate (contamination rate).</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood culture true-positive rate.</measure>
    <time_frame>Through study completion, an average of 1 year.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Neonatal Sepsis</condition>
  <arm_group>
    <arm_group_label>Any infant who will have a blood culture collected.</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bedside blood culture bottles weighing combined with educational interventions.</intervention_name>
    <description>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.</description>
    <arm_group_label>Any infant who will have a blood culture collected.</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All infants cared for in neonatal wards with suspected bacterial sepsis who have blood&#xD;
        culture collected. All infants from birth to discharge will be considered eligible for the&#xD;
        study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Any infant in a neonatal ward who has a blood culture collected (either early-onset or&#xD;
        late-onset sepsis suspected).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - There is no exclusion criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>4 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pawel Krajewski, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Warsaw</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Justyna Romańska, MD</last_name>
    <phone>225830340</phone>
    <phone_ext>+48</phone_ext>
    <email>justyna_romanska@gazeta.pl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tomasz Wawrzoniak, MD</last_name>
    <phone>225830336</phone>
    <phone_ext>+48</phone_ext>
    <email>wawrzon@mp.pl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Division of Neonatology and Neonatal Intensive Care, 1st Department of Obstetrics and Gynaecology, The Medical University of Warsaw</name>
      <address>
        <city>Warsaw</city>
        <state>Warszawa</state>
        <zip>02-015</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Department of Neonatology, Orlowski Public Teaching Hospital, Centre of Medical Postgraduate Education</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tomasz Wawrzoniak</last_name>
      <email>wawrzon@mp.pl</email>
    </contact>
    <investigator>
      <last_name>Tomasz Wawrzoniak</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Neonatal Unit, Holy Family Hospital</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tomasz Wawrzoniak</last_name>
      <email>wawrzon@mp.pl</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Specialistic Hospital 'Inflancka'</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tomasz Wawrzoniak</last_name>
      <email>wawrzon@mp.pl</email>
    </contact>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <reference>
    <citation>Puopolo KM, Benitz WE, Zaoutis TE; COMMITTEE ON FETUS AND NEWBORN; COMMITTEE ON INFECTIOUS DISEASES. Management of Neonates Born at &gt;/=35 0/7 Weeks' Gestation With Suspected or Proven Early-Onset Bacterial Sepsis. Pediatrics. 2018 Dec;142(6):e20182894. doi: 10.1542/peds.2018-2894.</citation>
    <PMID>30455342</PMID>
  </reference>
  <reference>
    <citation>Cantey JB, Baird SD. Ending the Culture of Culture-Negative Sepsis in the Neonatal ICU. Pediatrics. 2017 Oct;140(4):e20170044. doi: 10.1542/peds.2017-0044. Epub 2017 Sep 19. No abstract available.</citation>
    <PMID>28928289</PMID>
  </reference>
  <reference>
    <citation>Mukhopadhyay S, Taylor JA, Von Kohorn I, Flaherman V, Burgos AE, Phillipi CA, Dhepyasuwan N, King E, Dhudasia M, Puopolo KM. Variation in Sepsis Evaluation Across a National Network of Nurseries. Pediatrics. 2017 Mar;139(3):e20162845. doi: 10.1542/peds.2016-2845. Epub 2017 Feb 8.</citation>
    <PMID>28179485</PMID>
  </reference>
  <reference>
    <citation>Stoll BJ, Hansen N, Fanaroff AA, Wright LL, Carlo WA, Ehrenkranz RA, Lemons JA, Donovan EF, Stark AR, Tyson JE, Oh W, Bauer CR, Korones SB, Shankaran S, Laptook AR, Stevenson DK, Papile LA, Poole WK. Late-onset sepsis in very low birth weight neonates: the experience of the NICHD Neonatal Research Network. Pediatrics. 2002 Aug;110(2 Pt 1):285-91. doi: 10.1542/peds.110.2.285.</citation>
    <PMID>12165580</PMID>
  </reference>
  <reference>
    <citation>Garber SJ, Puopolo KM. Prevention of Central Line-Associated Bloodstream Infections Among Infants in the Neonatal Intensive Care Unit. 2015;16(4):e211-e20.</citation>
  </reference>
  <reference>
    <citation>Shoji K, Tsuboi N, Arakawa R, Ide K, Mikami M, Kato A, Miyairi I. Continuous Monitoring and Feedback Optimizes Blood Volume Inoculated Into Culture Bottles in the Pediatric Intensive Care Unit. J Pediatric Infect Dis Soc. 2019 May 11;8(2):166-169. doi: 10.1093/jpids/piy061.</citation>
    <PMID>30010914</PMID>
  </reference>
  <reference>
    <citation>Schelonka RL, Chai MK, Yoder BA, Hensley D, Brockett RM, Ascher DP. Volume of blood required to detect common neonatal pathogens. J Pediatr. 1996 Aug;129(2):275-8. doi: 10.1016/s0022-3476(96)70254-8.</citation>
    <PMID>8765627</PMID>
  </reference>
  <reference>
    <citation>Connell TG, Rele M, Cowley D, Buttery JP, Curtis N. How reliable is a negative blood culture result? Volume of blood submitted for culture in routine practice in a children's hospital. Pediatrics. 2007 May;119(5):891-6. doi: 10.1542/peds.2006-0440.</citation>
    <PMID>17473088</PMID>
  </reference>
  <reference>
    <citation>Buttery JP. Blood cultures in newborns and children: optimising an everyday test. Arch Dis Child Fetal Neonatal Ed. 2002 Jul;87(1):F25-8. doi: 10.1136/fn.87.1.f25.</citation>
    <PMID>12091285</PMID>
  </reference>
  <reference>
    <citation>Khare R, Kothari T, Castagnaro J, Hemmings B, Tso M, Juretschko S. Active Monitoring and Feedback to Improve Blood Culture Fill Volumes and Positivity Across a Large Integrated Health System. Clin Infect Dis. 2020 Jan 2;70(2):262-268. doi: 10.1093/cid/ciz198.</citation>
    <PMID>30873522</PMID>
  </reference>
  <reference>
    <citation>Cattoir L, Claessens J, Cartuyvels R, Van den Abeele AM. How to achieve accurate blood culture volumes: the BD BACTEC FX blood volume monitoring system as a measuring instrument and educational tool. Eur J Clin Microbiol Infect Dis. 2018 Sep;37(9):1621-1626. doi: 10.1007/s10096-018-3291-x. Epub 2018 Jun 7.</citation>
    <PMID>29882176</PMID>
  </reference>
  <reference>
    <citation>Shim H, Kim K, Uh Y, Seo D, Kim H, Yoon Y. The Development and Evaluation of Blood Volume Measuring System for Blood Culture Quality Improvement. Journal of Testing and Evaluation. 2012;40.</citation>
  </reference>
  <reference>
    <citation>Libertin CR, Sacco KA, Peterson JH. Education and coaching to optimise blood culture volumes: continuous quality improvement in microbiology. BMJ Open Qual. 2018 Jul 21;7(3):e000228. doi: 10.1136/bmjoq-2017-000228. eCollection 2018.</citation>
    <PMID>30057953</PMID>
  </reference>
  <reference>
    <citation>Birkhamshaw E, Winzor G. Increasing the volume of blood received in adult paired blood culture bottles at a regional public health laboratory: results of a quality improvement project to optimise the diagnosis of bacteraemia. Infect Prev Pract. 2019 Apr 19;1(1):100007. doi: 10.1016/j.infpip.2019.100007. eCollection 2019 Mar.</citation>
    <PMID>34368673</PMID>
  </reference>
  <reference>
    <citation>Ohnishi T, Kamimaki I, Kobayashi R, Nakatogawa K, Amemiya A, Mishima Y, Asato S, Shikoro N, Nakazawa M. Verification of blood volume for blood culture and detection rate in pediatrics. J Infect Chemother. 2020 May;26(5):471-474. doi: 10.1016/j.jiac.2019.12.008. Epub 2019 Dec 31.</citation>
    <PMID>31899078</PMID>
  </reference>
  <reference>
    <citation>Singh MP, Balegar V KK, Angiti RR. The practice of blood volume submitted for culture in a neonatal intensive care unit. Arch Dis Child Fetal Neonatal Ed. 2020 Nov;105(6):600-604. doi: 10.1136/archdischild-2019-318080. Epub 2020 Mar 20.</citation>
    <PMID>32198199</PMID>
  </reference>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>June 30, 2022</last_update_submitted>
  <last_update_submitted_qc>June 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Warsaw</investigator_affiliation>
    <investigator_full_name>PAWEL KRAJEWSKI, MD</investigator_full_name>
    <investigator_title>Head of the Division of Neonatology</investigator_title>
  </responsible_party>
  <keyword>blood culture</keyword>
  <keyword>newborn</keyword>
  <keyword>blood volume</keyword>
  <keyword>quality improvement</keyword>
  <keyword>neonatal sepsis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neonatal Sepsis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Immediately following publication. No end date.</ipd_time_frame>
    <ipd_access_criteria>Anyone who provides a methodologically sound proposal.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04455022
org study id: VOB4C TRIAL'20
nct id: NCT04455022
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Other
time perspective: Prospective
measure: The volume of blood submitted for culture.
time frame: Through study completion, an average of 1 year.
description: 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.
measure: The use of systemic antibiotics.
time frame: Through study completion, an average of 1 year.
description: 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.
measure: Blood culture false-positive rate (contamination rate).
time frame: Through study completion, an average of 1 year.
description: 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.
measure: Blood culture true-positive rate.
time frame: Through study completion, an average of 1 year.
description: 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.
arm group label: Any infant who will have a blood culture collected.
description: 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.
intervention type: Other
intervention name: Bedside blood culture bottles weighing combined with educational interventions.
description: 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.
arm group label: Any infant who will have a blood culture collected.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 4 Months
healthy volunteers: No
last name: Pawel Krajewski, MD, PhD
role: Principal Investigator
affiliation: Medical University of Warsaw
last name: Justyna Romańska, MD
phone: 225830340
phone ext: +48
email: justyna_romanska@gazeta.pl
last name: Tomasz Wawrzoniak, MD
phone: 225830336
phone ext: +48
email: wawrzon@mp.pl
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Poland
citation: Puopolo KM, Benitz WE, Zaoutis TE; COMMITTEE ON FETUS AND NEWBORN; COMMITTEE ON INFECTIOUS DISEASES. Management of Neonates Born at >/=35 0/7 Weeks' Gestation With Suspected or Proven Early-Onset Bacterial Sepsis. Pediatrics. 2018 Dec;142(6):e20182894. doi: 10.1542/peds.2018-2894.
PMID: 30455342
citation: Cantey JB, Baird SD. Ending the Culture of Culture-Negative Sepsis in the Neonatal ICU. Pediatrics. 2017 Oct;140(4):e20170044. doi: 10.1542/peds.2017-0044. Epub 2017 Sep 19. No abstract available.
PMID: 28928289
citation: Mukhopadhyay S, Taylor JA, Von Kohorn I, Flaherman V, Burgos AE, Phillipi CA, Dhepyasuwan N, King E, Dhudasia M, Puopolo KM. Variation in Sepsis Evaluation Across a National Network of Nurseries. Pediatrics. 2017 Mar;139(3):e20162845. doi: 10.1542/peds.2016-2845. Epub 2017 Feb 8.
PMID: 28179485
citation: Stoll BJ, Hansen N, Fanaroff AA, Wright LL, Carlo WA, Ehrenkranz RA, Lemons JA, Donovan EF, Stark AR, Tyson JE, Oh W, Bauer CR, Korones SB, Shankaran S, Laptook AR, Stevenson DK, Papile LA, Poole WK. Late-onset sepsis in very low birth weight neonates: the experience of the NICHD Neonatal Research Network. Pediatrics. 2002 Aug;110(2 Pt 1):285-91. doi: 10.1542/peds.110.2.285.
PMID: 12165580
citation: Garber SJ, Puopolo KM. Prevention of Central Line-Associated Bloodstream Infections Among Infants in the Neonatal Intensive Care Unit. 2015;16(4):e211-e20.
citation: Shoji K, Tsuboi N, Arakawa R, Ide K, Mikami M, Kato A, Miyairi I. Continuous Monitoring and Feedback Optimizes Blood Volume Inoculated Into Culture Bottles in the Pediatric Intensive Care Unit. J Pediatric Infect Dis Soc. 2019 May 11;8(2):166-169. doi: 10.1093/jpids/piy061.
PMID: 30010914
citation: Schelonka RL, Chai MK, Yoder BA, Hensley D, Brockett RM, Ascher DP. Volume of blood required to detect common neonatal pathogens. J Pediatr. 1996 Aug;129(2):275-8. doi: 10.1016/s0022-3476(96)70254-8.
PMID: 8765627
citation: Connell TG, Rele M, Cowley D, Buttery JP, Curtis N. How reliable is a negative blood culture result? Volume of blood submitted for culture in routine practice in a children's hospital. Pediatrics. 2007 May;119(5):891-6. doi: 10.1542/peds.2006-0440.
PMID: 17473088
citation: Buttery JP. Blood cultures in newborns and children: optimising an everyday test. Arch Dis Child Fetal Neonatal Ed. 2002 Jul;87(1):F25-8. doi: 10.1136/fn.87.1.f25.
PMID: 12091285
citation: Khare R, Kothari T, Castagnaro J, Hemmings B, Tso M, Juretschko S. Active Monitoring and Feedback to Improve Blood Culture Fill Volumes and Positivity Across a Large Integrated Health System. Clin Infect Dis. 2020 Jan 2;70(2):262-268. doi: 10.1093/cid/ciz198.
PMID: 30873522
citation: Cattoir L, Claessens J, Cartuyvels R, Van den Abeele AM. How to achieve accurate blood culture volumes: the BD BACTEC FX blood volume monitoring system as a measuring instrument and educational tool. Eur J Clin Microbiol Infect Dis. 2018 Sep;37(9):1621-1626. doi: 10.1007/s10096-018-3291-x. Epub 2018 Jun 7.
PMID: 29882176
citation: Shim H, Kim K, Uh Y, Seo D, Kim H, Yoon Y. The Development and Evaluation of Blood Volume Measuring System for Blood Culture Quality Improvement. Journal of Testing and Evaluation. 2012;40.
citation: Libertin CR, Sacco KA, Peterson JH. Education and coaching to optimise blood culture volumes: continuous quality improvement in microbiology. BMJ Open Qual. 2018 Jul 21;7(3):e000228. doi: 10.1136/bmjoq-2017-000228. eCollection 2018.
PMID: 30057953
citation: Birkhamshaw E, Winzor G. Increasing the volume of blood received in adult paired blood culture bottles at a regional public health laboratory: results of a quality improvement project to optimise the diagnosis of bacteraemia. Infect Prev Pract. 2019 Apr 19;1(1):100007. doi: 10.1016/j.infpip.2019.100007. eCollection 2019 Mar.
PMID: 34368673
citation: Ohnishi T, Kamimaki I, Kobayashi R, Nakatogawa K, Amemiya A, Mishima Y, Asato S, Shikoro N, Nakazawa M. Verification of blood volume for blood culture and detection rate in pediatrics. J Infect Chemother. 2020 May;26(5):471-474. doi: 10.1016/j.jiac.2019.12.008. Epub 2019 Dec 31.
PMID: 31899078
citation: Singh MP, Balegar V KK, Angiti RR. The practice of blood volume submitted for culture in a neonatal intensive care unit. Arch Dis Child Fetal Neonatal Ed. 2020 Nov;105(6):600-604. doi: 10.1136/archdischild-2019-318080. Epub 2020 Mar 20.
PMID: 32198199
responsible party type: Principal Investigator
investigator affiliation: Medical University of Warsaw
investigator full name: PAWEL KRAJEWSKI, MD
investigator title: Head of the Division of Neonatology
mesh term: Neonatal Sepsis
sharing ipd: Yes
ipd 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 info type: Study Protocol
ipd time frame: Immediately following publication. No end date.
ipd access criteria: Anyone who provides a methodologically sound proposal.