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

• Conditions: Neonatal Sepsis
• Interventions: Other: Bedside blood culture bottles weighing combined with educational interventions.

• Registration Number: NCT04455022
• Lead Sponsor: Medical University of Warsaw

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.

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 Timeline

• Study First Submitted: 2020-06-22
• Study First Submitted QC: 2020-06-29
• Study First Posted: 2020-07-02
• Study Start: 2022-05-10
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-05
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Any infant who will have a blood culture collected.	Bedside blood culture bottles weighing combined with educational interventions.	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.

Primary Outcome Measures

Name	Time	Method
The volume of blood submitted for culture.	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.

Secondary Outcome Measures

Name	Time	Method
The use of systemic antibiotics.	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.
Blood culture false-positive rate (contamination rate).	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.
Blood culture true-positive rate.	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.

Trial Locations

Locations (4)

Division of Neonatology and Neonatal Intensive Care, 1st Department of Obstetrics and Gynaecology, The Medical University of Warsaw; 🇵🇱 Warsaw, Warszawa, Poland

Department of Neonatology, Orlowski Public Teaching Hospital, Centre of Medical Postgraduate Education; 🇵🇱 Warsaw, Poland

Specialistic Hospital 'Inflancka'; 🇵🇱 Warsaw, Poland

Neonatal Unit, Holy Family Hospital; 🇵🇱 Warsaw, Poland