NCT04455022

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

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.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 4 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Neonatal Sepsis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-05-10
• Primary completion: 2023-07-01
• Completion: 2023-07-08
• First posted: 2020-07-02
• Last updated: 2022-07-05

Locations

4 sites across 1 country: Poland