An observational study in Neonatal Sepsis, sponsored by Medical University of Warsaw. Status unknown at 4 sites in Poland. Open to participants aged Up to 4 Months. Per ClinicalTrials.gov, last updated 2022-07-05.
Sponsored by Medical University of Warsaw · Observational
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.
183 studies on the registry are indexed under Neonatal Sepsis; 41 are open to participants now.
This study's planned enrollment of 600 is above the median of 200 across 84 observational studies indexed under Neonatal Sepsis.
Browse Neonatal Sepsis studies →Medical University of Warsaw is the lead sponsor of 316 studies on the registry; 87 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
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.
Time frame: Through study completion, an average of 1 year.
The use of systemic antibiotics.
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.
Time frame: Through study completion, an average of 1 year.
Blood culture false-positive rate (contamination rate).
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.
Time frame: Through study completion, an average of 1 year.
Blood culture true-positive rate.
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.
Time frame: Through study completion, an average of 1 year.
Plan to share: Yes — 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.
Supporting information: Study protocol
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Medical University of Warsaw