跳至主要内容
临床试验/NCT00716781
NCT00716781已完成不适用

Management of Infants Born to Group B Streptococcus Positive Mothers: Laboratory Tests vs Physical Examination

IRCCS Burlo Garofolo0 个研究点目标入组 16,394 人开始时间: 2004年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16,394
主要终点
Number of infants treated with antibiotics

研究概览

简要总结

Intrapartum antibiotic prophylaxis has greatly decreased but not abolished early-onset neonatal sepsis caused by GBS. According to current recommendations, the evaluation of infants at risk for GBS sepsis should include a complete blood count (CBC), WBC differential, a blood culture (BC) and a period of observation. The usefulness of CBC and BC in the evaluation process is not firmly established.

详细描述

After implementation of appropriate guidelines, early-onset GBS sepsis has become a low incidence disease (CDC). Recent rates are as low as 0.34 cases /1000 live births. According to CDC recommendations, the evaluation of infants at risk for GBS sepsis should include a complete blood count (CBC), WBC differential, a blood culture (BC) and a period of observation. The usefulness of CBC and BC in the evaluation process is not firmly established. There are several reviews on the predictive value of CBC and putative markers of early onset neonatal sepsis, but there seems to be no ideal laboratory test to assist the clinician in the diagnosis (Fowlie 1998, Malik 2003, Ottolini 2003). Given the continuing concerns about the reliability of laboratory tests, one may ask the question of whether physical examination might be at least as good as haematological indices. We are not aware of studies assessing the value of physical examination vs CBC, in the evaluation of asymptomatic at risk newborns.

The aim of this study was to compare two approaches in the management of infants at risk for GBS sepsis: laboratory tests (CBC, differential and BC) with observation vs clinical observation alone.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All newborns born in Friuli Venezia Giulia Region (Italy)

排除标准

  • 未提供

结局指标

主要结局

Number of infants treated with antibiotics

时间窗: Study period

次要结局

  • Time elapsed from the onset of symptoms to the beginning of antibiotic treatment(Study period)

研究者

发起方
IRCCS Burlo Garofolo
申办方类型
Other

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