Contribution of Computerized Real Time Analyses of Cardio-respiratory Signals to the Diagnosis of Infection in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 525
- 试验地点
- 3
- 主要终点
- Diagnosis of proven or suspected bacterial infection
研究概览
简要总结
Hospital-acquired infections are common complications in preterm infants. The diagnosis has to be fast and accurate. Indeed, the early identification of a suspected infection is very important, since the early administration of antibiotics lowers the risk of septic shock and improves long term outcome in the infected newborns who survive. Besides, a high specificity in the diagnosis of infection allows for the reduction of inappropriate treatment and thus prevents the emergence of antibiotic resistance.
The aim of this study is to develop a computer-assisted diagnosis tool, based on the real time analysis of cardio-respiratory signals, to aid the neonatologist in the diagnosis of infection of the preterm infant, at the bedside.
详细描述
Hospital-acquired infections increase morbidity and mortality in the preterm infants. Early diagnosis of infection is difficult mainly due to the poor performance of clinical signs and to the need for invasive procedure to get blood tests. However, early administration of antibiotics lowers the risk of septic shock and improves long term outcome in the infected newborns who survive. Many clinical features have been described, associated with an ongoing infection but they are inconsistent, variable and nonspecific. Similarly, many invasive laboratory tests have been proposed for the diagnosis of infection in the newborn but they all need blood sampling and none has a good predictive value.
The combined analysis of the heart rate and respiratory characteristics appears to be a promising tool for the diagnosis of infection in the preterm infants. These signals are non-invasively recorded and their computerized real time analyses would allow for a continuous assessment of the risk of infection.
The main objective is to test the hypothesis that the analyses of the variability of the cardiac cycle duration, the variability of the respiratory cycle amplitude and duration, and their relationships, can significantly improve the performance of the diagnosis of late onset infection in the preterm infant at the bedside in neonatal units.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 24 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm birth before < 32wks and > 24wks
- •birth weight > 500g
- •postnatal age> 3 days
- •postconceptional age < 34wks
- •parents information and collection of non-opposition
排除标准
- •malformative syndrome
- •severe neurological injury (IVH grade 4, cavitary periventricular leukomalacia, perinatal asphyxia post ischemia)
结局指标
主要结局
Diagnosis of proven or suspected bacterial infection
时间窗: Within the hospitalisation with an anticipated mean duration of 10 weeks
The primary outcome will be the efficiency (area under curve, sensitivity, specificity, false-positive and false-negative) of the combined analysis of heart rate and respiratory characteristics for the diagnosis of proven or suspected bacterial infection.
次要结局
- Inflammation without proven or suspected bacterial infection defined as follows: a 6 hours period with CRP> 5 mg/L not classified as proven or suspected bacterial infection.(Within the hospitalisation with an anticipated mean duration of 2 to 10 weeks)
- Periods of discomfort defined as at least two EDIN scores above 3 in a 6 hours period(Within the hospitalisation with an anticipated mean duration of 2 to 10 weeks)