跳至主要内容
临床试验/NCT03117907
NCT03117907已完成不适用

Comparison of Peripheral Perfusion Level Between Two Groups of Newborns According to Their Infectious Status Defined by the Criteria of the Center for Disease Control and Prevention (CDC)

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2016年3月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
2
主要终点
Measurement of the mean value of the perfusion index (PI) measured on the right hand

研究概览

简要总结

Despite advances in medicine, secondary neonatal infection remains a continuing concern because of the associated high morbidity and mortality. The usual mechanism of infection responds to the transmission of germs by the equipment used for care (eg, catheters) and by the hands of caregivers. In preterm infants in particular, some infections can also have an endogenous source, by translocation of colonization germs present in the digestive tract.

The first line of prevention of secondary infection corresponds to compliance with the rules of hand hygiene, work surfaces and equipment carried out, the effect of which on the control of the incidence of secondary infection is regularly demonstrated. When declared, bacterial infection should be treated as quickly as possible with appropriate and effective antibiotics to preserve the healing prognosis. Compared to the infant and the larger child, clinical signs of calling are atypical and discrete. In the absence of staff trained to monitor newborns specifically, there is a real risk of discovering the existence of the infection only at an advanced stage corresponding, among other things, to circulatory collapse. This risk is not completely excluded, even with experienced practitioners, because the positive signs are rude and may go unnoticed (eg, signs of calling such as fever are rare in the newborn). Support for early diagnosis of neonatal infection by automatic monitoring systems has reduced mortality by 30% in the units where it has been applied. This is probably due to the fact that early warning made it possible to start the antibiotic treatment earlier and to complete the bacteriological diagnosis in order to better orient the therapeutic attitude. The best criteria for early diagnosis by automated systems were provided by the statistical analysis of cardiac variability, the results of the research and correspond to the standard deviation, the asymmetry and the entropy of the series d Cardiac intervals. Since microbial aggression has an impact on many vegetative variables outside of the electrocardiogram, our current research aims to determine whether the analysis of the perfusion index (PI) Which are of interest for detecting disturbances in the early stages of infection in newborns. IP corresponds to the ratio of the amplitude of the oscillating phase to the intensity of the constant part of the opto-plethysmography wave; It is obtained from signals recorded in a non-invasive manner by the same infrared sensor for pulse oximetry.

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
27 Weeks 至 42 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Newborn of corrected age between 27 SA and 42 SA with at least 72 hours of postnatal age
  • Presence of clinical or biological criteria of infection according to CDC definitions
  • Absence of clinical or biological criteria for infection according to CDC definitions

排除标准

  • Congenital malformation neurological, cardiac, respiratory, vascular and cutaneous.
  • A proven episode of materno-fetal infection

结局指标

主要结局

Measurement of the mean value of the perfusion index (PI) measured on the right hand

时间窗: 3 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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