跳至主要内容
临床试验/NCT05089760
NCT05089760尚未招募不适用

Microbiology, Antimicrobial Resistance and Outcomes of Neonatal Sepsis in Chinese Neonatal Intensive Care Units

Children's Hospital of Fudan University0 个研究点目标入组 1,200 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,200
主要终点
Overall mortality

研究概览

简要总结

Neonatal sepsis remains one of the most important cause of mortality and morbidities in China. This study will establish a prospective registral cohort of all infants with culture-proven neonatal sepsis in Chinese NICUs participating in the Chinese Neonatal Network (CHNN). The microbiology, antimicrobial resistance patterns and neonatal outcomes will be described in detail for this cohort.

详细描述

All infants with culture-proven sepsis in NICUs of CHNN will be enrolled in the study. Detailed data on microbiology, resistance pattern, neonatal mortality and morbidities will be collected and described. Risk factors for multi-resistant bacteria infections and for sepsis-related mortality will be identified.

研究设计

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

入排标准

年龄范围
1 Hour 至 1 Month(Child)
性别
All
接受健康志愿者

入选标准

  • Admitted to CHNN NICUs from 2022.1.1 to 2023.12.31
  • Diagnosed with culture-proven sepsis

排除标准

  • 未提供

结局指标

主要结局

Overall mortality

时间窗: About 3 months from admission to discharge or death

Incidence of death during the study period

次要结局

  • Incidence of septic shock(About 3 months from admission to discharge or death)
  • Incidence of multiorgan dysfunction(About 3 months from admission to discharge or death)
  • Sepsis-related mortality (within 7 days of sepsis)(About 3 months from admission to discharge or death)
  • Incidence of respiratory failure(About 3 months from admission to discharge or death)
  • Incidence of disseminated intravascular coagulation (DIC)(About 3 months from admission to discharge or death)
  • Incidence of necrotizing enterocolitis(About 3 months from admission to discharge or death)
  • Incidence of meningitis(About 3 months from admission to discharge or death)
  • Length of antibiotic treatment(About 3 months from admission to discharge or death)
  • Type and quantity of transfusion(About 3 months from admission to discharge or death)
  • Incidence of renal failure(About 3 months from admission to discharge or death)
  • Incidence of brain injury(About 3 months from admission to discharge or death)
  • Length of hospital stay(About 3 months from admission to discharge or death)

研究者

申办方类型
Other
责任方
Sponsor

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