Comparison of clinical characteristics and outcomes of neonates with culture-negative versus culture-positive sepsis: a prospective cohort study
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
Raghvendra Singh Patel
Bharati hospital and research centre
