The Volume of Blood Submitted for Culture in Neonates

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Neonatal Sepsis

Clinical Trial Details

NCT number	NCT04455022
Study type	Observational
Source	Medical University of Warsaw
Contact	Justyna Romanska, MD
Phone	225830340
Email	justyna_romanska@gazeta.pl
Status	Recruiting
Phase
Start date	May 10, 2022
Completion date	July 8, 2023

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms