跳至主要内容
临床试验/NCT04513691
NCT04513691已完成不适用

A Retrospective Chart Review of Newborns With the Presence of Confirmed or Suspected Maternal Chorioamnionitis and Utilization of the Early Onset Sepsis Calculator

Pediatrix1 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2020年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Pediatrix
入组人数
236
试验地点
1
主要终点
To determine whether the usage of Neonatal EOS Calculator measuring laboratory testing in newborns with a maternal diagnosis of suspected or confirmed chorioamnionitis (CAM) in our newborn nursery.

研究概览

简要总结

This study will review practices in relation to chorioamnionitis (CAM) before and after to the implementation of the Neonatal Early-Onset Sepsis (EOS) Risk Calculator to determine the effect in the nursery at Banner - University Medical Center Phoenix. Newborns enrolled will be at least 35 weeks gestational age (GA) and have a maternal diagnosis of at least suspected or confirmed CAM. The data will include those newborns whose assessment and treatment were not guided by the EOS calculator which was implemented on August 28, 2019 and those with which the EOS calculator was utilized. A secondary objective is to show the economic impact with utilization of the EOS calculator. Data collected will include full laboratory workups including complete blood counts (CBC), blood cultures, antibiotic usage, length of time in the newborn nursery and total length of stay.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
35 Weeks 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Asymptomatic newborns 35 weeks or greater GA born at Banner - University Medical Center Phoenix whose mothers were determined or suspected to have CAM.

排除标准

  • Direct NICU Admissions
  • Subjects may be excluded at Investigator discretion

结局指标

主要结局

To determine whether the usage of Neonatal EOS Calculator measuring laboratory testing in newborns with a maternal diagnosis of suspected or confirmed chorioamnionitis (CAM) in our newborn nursery.

时间窗: August 28, 2018 through August 28, 2020

To determine the usage of EOS Calculator measuring laboratory testing.

To determine whether the usage of Neonatal EOS Calculator decreased antibiotic usage in newborns with a maternal diagnosis of suspected or confirmed chorioamnionitis (CAM) in our newborn nursery.

时间窗: August 28, 2018 through August 28, 2020

To determine the usage of EOS Calculator measuring decreased antibiotic usage.

To determine whether the usage of Neonatal EOS Calculator LOS in newborns with a maternal diagnosis of suspected or confirmed chorioamnionitis (CAM) in our newborn nursery.

时间窗: August 28, 2018 through August 28, 2020

To determine the usage of EOS Calculator measuring length of stay (LOS) in newborns

次要结局

  • To evaluate the economic impact after the implementation of the EOS Calculator in laboratory tests in newborn nursery and total length of hospital stay.(August 28, 2018 through August 28, 2020)
  • To evaluate the economic impact after the implementation of the EOS Calculator in LOS in newborn nursery and total length of hospital stay.(August 28, 2018 through August 28, 2020)
  • To evaluate the economic impact after the implementation of the EOS Calculator in antibiotic usage in newborn nursery and total length of hospital stay.(August 28, 2018 through August 28, 2020)

研究者

发起方
Pediatrix
申办方类型
Other
责任方
Sponsor

研究点 (1)

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