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临床试验/NCT04893343
NCT04893343已完成不适用

Antibiotic Use in a Neonatal Intensive Care Unit Practicing Integrative Medicine

ARCIM Institute Academic Research in Complementary and Integrative Medicine1 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2021年6月15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
入组人数
246
试验地点
1
主要终点
Antibiotic prescription rate

研究概览

简要总结

The goal of this study is to describe the antibiotic use in a neonatal intensive care unit (NICU) in Germany that is practising integrative medicine. The investigators will review hospital records to find out how often and how long antibiotics were given to newborns; compare antibiotic use to other NICU in the same area; describe how sick infected newborns were (comparing those treated with or without antibiotics); and describe which anthroposophic medicines were used, how often and if there were safety problems.

详细描述

A retrospective study, analysing antibiotic use in a level 2 neonatology intensive care unit (NICU) in Germany over a 4-year period from 2014 to 2017. The study will analyse frequency of antibiotic prescribing; compare antibiotic use to other level 2 NICU; compare clinical and laboratory parameters among neonates with infectious disease diagnosis managed with or without antibiotics; use and tolerability of anthroposophic medicinal products.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
0 Days 至 30 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Admission to neonatal intensive care unit

排除标准

  • 未提供

结局指标

主要结局

Antibiotic prescription rate

时间窗: January 1, 2014 to December 31, 2017

Number of antibiotic treatment days per 100 hospital days

次要结局

  • Antibiotic treatment duration(January 1, 2014 to December 31, 2017)
  • Clinical and laboratory parameters in neonates with infectious disease diagnosis: Mother group B streptococcus positive(January 1, 2014 to December 31, 2017)
  • Clinical and laboratory parameters in neonates with infectious disease diagnosis: Low birthweight(January 1, 2014 to December 31, 2017)
  • Clinical and laboratory parameters in neonates with infectious disease diagnosis: Infant fever on admission(January 1, 2014 to December 31, 2017)
  • Clinical and laboratory parameters in neonates with infectious disease diagnosis: CRP maximum value(January 1, 2014 to December 31, 2017)
  • Use of anthroposophic medications: frequency of use(January 1, 2014 to December 31, 2017)
  • Clinical and laboratory parameters in neonates with infectious disease diagnosis: Premature rupture of membranes(January 1, 2014 to December 31, 2017)
  • Clinical and laboratory parameters in neonates with infectious disease diagnosis: Leukocyte count maximum value(January 1, 2014 to December 31, 2017)
  • Safety of anthroposophic medications: adverse drug reactions(January 1, 2014 to December 31, 2017)
  • Antibiotic use compared to other level 2 NICU in same geographic area(January 1, 2014 to December 31, 2017)
  • Clinical and laboratory parameters in neonates with infectious disease diagnosis: pH umbilical artery at birth(January 1, 2014 to December 31, 2017)
  • Antibiotic type(January 1, 2014 to December 31, 2017)
  • Use of anthroposophic medications: medication names(January 1, 2014 to December 31, 2017)
  • Safety of anthroposophic medications: side effects(January 1, 2014 to December 31, 2017)

研究者

发起方
ARCIM Institute Academic Research in Complementary and Integrative Medicine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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