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

NCT04455022 | Unknown

• 1 other identifier: VOB4C TRIAL'20
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Neonatal Sepsis

Keywords

blood culture; newborn; blood volume; quality improvement; neonatal sepsis

Outcome Measures

Primary Outcomes (1)

• The volume of blood submitted for culture.

  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 Outcomes (3)

• The use of systemic antibiotics.

  Through study completion, an average of 1 year.

• Blood culture false-positive rate (contamination rate).

  Through study completion, an average of 1 year.

• Blood culture true-positive rate.

  Through study completion, an average of 1 year.

Study Arms (1)

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.

Interventions

Bedside blood culture bottles weighing combined with educational interventions. OTHER

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.

Any infant who will have a blood culture collected.

Eligibility Criteria

• Age: Up to 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (4)

Division of Neonatology and Neonatal Intensive Care, 1st Department of Obstetrics and Gynaecology, The Medical University of Warsaw

Warsaw, Warszawa, 02-015, Poland

WITHDRAWN

Department of Neonatology, Orlowski Public Teaching Hospital, Centre of Medical Postgraduate Education

Warsaw, Poland

RECRUITING

Neonatal Unit, Holy Family Hospital

Warsaw, Poland

RECRUITING

Specialistic Hospital 'Inflancka'

Warsaw, Poland

RECRUITING

Related Publications (16)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Garber SJ, Puopolo KM. Prevention of Central Line-Associated Bloodstream Infections Among Infants in the Neonatal Intensive Care Unit. 2015;16(4):e211-e20.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pawel Krajewski, MD, PhD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justyna Romańska, MD

CONTACT

225830340; justyna_romanska@gazeta.pl

Tomasz Wawrzoniak, MD

CONTACT

225830336; wawrzon@mp.pl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Division of Neonatology

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: July 2, 2020
• Study Start: May 10, 2022
• Primary Completion: July 1, 2023
• Study Completion: July 8, 2023
• Last Updated: July 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone who provides a methodologically sound proposal.

Locations

PL (4)