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临床试验/NCT06637696
NCT06637696已完成不适用

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

Dr. Behcet Uz Children's Hospital1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2022年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
320
试验地点
1
主要终点
Blood Culture Contamination Rate

研究概览

简要总结

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).

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Newborns diagnosed with sepsis

排除标准

  • •Newborns receiving antibiotic treatment

研究组 & 干预措施

Blood Culture Bundle Group

Active Comparator

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.

干预措施: Blood Culture Bundle (Other)

Control Blood Culture Group

Placebo Comparator

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.

干预措施: Blood Culture Bundle (Other)

结局指标

主要结局

Blood Culture Contamination Rate

时间窗: 1 year

The primary purpose of this study is to compare the contamination rate of blood culture taken with the bundle method and the contamination rate of blood culture taken with the standard method.

次要结局

未报告次要终点

研究者

发起方
Dr. Behcet Uz Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Oğuz Han Kalkanlı

Medical Doctor

Dr. Behcet Uz Children's Hospital

研究点 (1)

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