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临床试验/NCT02858700
NCT02858700已完成不适用

Value for Cord Blood Procalcitonin to Diagnose Early Neonatal Bacterial Infection

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2009年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
550
试验地点
1
主要终点
value of the procalcitonin in the umbilical cord blood

研究概览

简要总结

After birth, in the presence of risk factors for early neonatal bacterial infection (IBNP), the pediatrician must make a difficult decision quickly or not to prescribe additional examinations and / or hospitalize or not the newborn in order to administer parenteral antibiotics. This decision takes into account several contextual data, (clinical, biological and bacteriological clinical data) to be considered simultaneously. These information lack sensitivity and specificity.

Therefore, the common attitude among newborns in many countries remains the achievement of a significant number of additional tests and the establishment, without a prior evidence of infection, intravenous empirical antibiotic therapy for 48 -72h at least in hospitalization. However, the diagnosis of IBNP posteriori, is often reversed. This attitude is:

  1. one source to higher health care costs (hospitalization, additional examinations)
  2. Selection of the bacterial ecology of the newborn and neonatal services and
  3. stress for the newborn and parents

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
1 Minute 至 30 Minutes(Child)
性别
All
接受健康志愿者

入选标准

  • Birth to motherhood.
  • Term > 34 weeks .
  • Presence of at least one of the factors of major or minor infection risk

排除标准

  • cord blood sample unavailable.
  • Death in the delivery room
  • Corticosteroids prenatally (modification of cytokine production ) .

结局指标

主要结局

value of the procalcitonin in the umbilical cord blood

时间窗: up to 1 hour

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 (1)

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