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临床试验/CTRI/2026/02/105038
CTRI/2026/02/105038尚未招募不适用

Comparison of clinical characteristics and outcomes of neonates with culture-negative versus culture-positive sepsis: a prospective cohort study

Bharati Hospital and Research Centr1 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2026年3月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
178
试验地点
1

研究概览

简要总结

Neonatal sepsis causes high morbidity and mortality in NICUs worldwide especially in low and middle income countries like India where 51 to 56.7 percent of cases are culture negative despite clinical signs. The Delhi Neonatal Infection Study found sepsis incidence at 14.3 percent with culture negative cases at 8.1 percent or 56.7 percent of total sepsis and mortality risks of 8.6 percent for culture negative and 27.7 percent for culture positive. Data on culture negative sepsis outcomes and management is limited and inconsistent. This study will measure its proportion in NICU admissions compare demographics risk factors presentation and outcomes with culture positive sepsis and test if culture negative cases have shorter recovery less severity and different antibiotic use to guide better care and stewardship.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • All Neonates (0 to 28 days) admitted to NICU during the study period and clinically suspected to have sepsis by the treating neonatal physician.

排除标准

  • Neonates (0 too 28 days) with the following conditions will be excluded from the study:
  • Major congenital anomalies incompatible with life
  • Blood culture not taken before starting antibiotics
  • Prior sepsis episode during the same admission and patient still not recovered
  • Only the first episode of sepsis for each patient will be included for analysis.

研究者

发起方
Bharati Hospital and Research Centr
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Raghvendra Singh Patel

Bharati hospital and research centre

研究点 (1)

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