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临床试验/NCT05743816
NCT05743816招募中不适用

Neonatal Antimicrobial Resistance and Outcome (neoAMRO)

St George's, University of London1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2019年7月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
800
试验地点
1
主要终点
Clinical characteristics

研究概览

简要总结

This is a multicentre observational study involving NNUs across the UK. Study personnel (Neonatologists and research Nurses) from these NNUs will identify eligible babies in whom a positive culture has been obtained.

This study will help identify the infections leading to death in babies on UK neonatal units, define the clinical characteristics of babies dying from infections, and describe the management of babies dying from infections with a specific focus in their antimicrobial treatment.

详细描述

The neonIN surveillance network captures data on episodes of invasive neonatal infection on a web-based database. Over 30 UK neonatal units currently contribute to this database in real-time. An episode of neonatal infection is defined as a positive culture collected from a normally sterile site such as the blood, cerebrospinal fluid (CSF) or urine (via catheter or suprapubic aspirate) for which clinicians prescribed at least five days of appropriate antibiotics. Clinical, demographic and microbiological data (including antimicrobial susceptibilities) are collected using a standardised online questionnaire. Denominator data regarding the total number of live-births and neonatal-admissions are collected for each neonatal unit.

Through our study we aim to understand and describe better those infections and risk factors that lead to death. The case-control study will enable us to determine if gaps in optimal management, such as the wrong antibiotic or the wrong dose, are associated with poor outcomes. We can then translate such information into practice and develop / improve clinical guidance in order to improve outcomes.

For the purpose of this study, we will request information on the baby's status (alive/died/not known) at 28 days after the positive culture was obtained. If the baby is alive, then this baby becomes eligible as a control. If the baby has died, then further details will be sought including the date of death and whether death was attributed to the infection.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
28 Days 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Clinical characteristics

时间窗: 5 years

To define the clinical characteristics of babies dying from infections

Management of infections

时间窗: 5 years

To describe the management of babies dying from infections with a specific focus in their antimicrobial treatment and the antimicrobial resistance profiles of the relevant organisms

Identifying infections

时间窗: 5 years

To identify the infections leading to death in babies on UK neonatal units

次要结局

  • Comparing bacterial infections(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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