The Effect of Implementation of Bundle for Preventing Blood Culture Contamination in Neonatal Intensive Care Unit

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-05-31

Brief Summary

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In this study, investigators aimed to evaluate the impact of blood culture bundles on the incidence of contamination in the neonatal intensive care unit (NICU).

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Detailed Description

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Infections are never as frequent and life-threatening as in the neonatal period. The lack of sepsis-specific findings in the neonatal period, the narrow repertoire of clinical findings in newborns, and the fact that non-infectious clinical conditions frequently encountered in this period have similar findings pose a serious problem for early diagnosis and treatment of neonatal sepsis. Another important problem is that early empirical antibiotic treatment without diagnostic confirmation has to be resorted to very frequently in order to avoid morbidity and more importantly mortality with early intervention. This leads to unnecessary and prolonged treatment of newborns with potentially dangerous broad-spectrum antibiotics as well as prolonged hospitalizations and significant costs.

The rate of contaminated blood culture in the neonatal period is 2.6-18%. In this study, investigators aimed to evaluate the impact of blood culture bundles on the incidence of contamination in the neonatal intensive care unit (NICU).

Conditions

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Newborn; Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

The study included a total of 320 (160 neonates in pre-bundle period, 160 neonates in post-bundle period) neonates.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Blood Culture Bundle Group

In this group, blood culture collection was performed using a checklist other than the standard criteria.The checklist for the blood culture contamination precaution package (Table 1) was prepared using guidelines from the Turkish Society of Clinical Microbiology.

Group Type ACTIVE_COMPARATOR

Blood Culture Bundle

Intervention Type OTHER

In this pre and post intervention study investigators aimed to evaluate the impact of a blood culture bundles on the incidence of blood culture contamination rates in NICU.

Control Blood Culture Group

In this group the standard practice in both periods was aseptic, non-contact technique for blood culture collection. For this purpose, hands were cleaned with antibacterial liquid soap (Klorhexin scrub antibacterial liquid soap 4-% Ekin Medical), the patient's skin was cleaned with povidone iodine 10% solution (Betadix 10% solution- Natural Medical Pharma) using sterile gloves, waited at least 30 seconds and then povidone iodine was removed from the skin with 70% alcohol.

Group Type PLACEBO_COMPARATOR

Blood Culture Bundle

Intervention Type OTHER

In this pre and post intervention study investigators aimed to evaluate the impact of a blood culture bundles on the incidence of blood culture contamination rates in NICU.

Interventions

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Blood Culture Bundle

In this pre and post intervention study investigators aimed to evaluate the impact of a blood culture bundles on the incidence of blood culture contamination rates in NICU.

Intervention Type OTHER