Febrile Infants - Diagnostic Assessment and Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 555
- 试验地点
- 6
- 主要终点
- Invasive bacterial infection
研究概览
简要总结
The purpose of this study is to assess how clinicians apply guidance in the assessment of febrile infants presenting the the Emergency Department. The measurable outcomes are:
Primary Objective Report the rates of serious and invasive bacterial infections in febrile infants
Secondary Objectives Report on the predictive value of different clinical features for predicting bacterial infections.
Report on the value of biomarkers for predicting serious and invasive bacterial infections.
Assess the performance of clinical practice guidelines for the assessment of febrile infants.
详细描述
The assessment of febrile infants is difficult. In the UK and Ireland current guidance advocates that most children under 3 months of age with a fever undergo a full septic screen including lumbar puncture and receive parenteral antibiotics. Approaches in the United States and Europe including the PECARN and StepByStep approach allow for the discharge home of some low risk young infants.
We intend to assess the current approach to febrile infants and compare that to the available clinical practice guidelines. We also intend to determine which clinical and/or laboratory features are most predictive of serious bacterial infection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 90 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any infant aged 0 to 90 days (inclusive) with a fever of 38 degrees centigrade or higher recorded in the Emergency Department.
排除标准
- 未提供
结局指标
主要结局
Invasive bacterial infection
时间窗: seven days
Invasive Bacterial Infection (non-contaminant) confirmed by culture or molecular diagnostic testing of a sterile site i.e. blood or cerebrospinal fluid (CSF). Staphylococcus epidermidis, Propionibacterium acnes, Streptococcus viridans, or Diphtheroides were considered contaminants.
Serious bacterial infections
时间窗: seven days
Urinary tract infections defined as growth of ≥100 000 cfu/mL
次要结局
未报告次要终点
研究者
Thomas Waterfield
Doctor
Belfast Health and Social Care Trust