跳至主要内容
临床试验/CTRI/2024/04/066153
CTRI/2024/04/066153尚未招募不适用

To Study Incidence and clinical outcomes of culture positive sepsis in a Level III NICU – a ambispective observational study

Dr Sonali Amol Avale1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2024年5月7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
800
试验地点
1
主要终点
To study the incidence of MDR and XDR in NICU

研究概览

简要总结

Sepsis is one of the three most common causes of neonatal deaths globally. Most infection-related deaths in the neonatal period occur in low-income and middle-income countries due to poor hygiene and suboptimal practices for infection control. A significant proportion of these deaths are caused by multidrug-resistant pathogens.Despite the massive burden, few high-quality data about neonatal sepsis are available from these countries.The currently available multisite studies on sepsis are from well-established surveillance networks in high income countries such as the USA, the UK,  and Germany . Such infection surveillance networks are a rarity in low-income and middle-income countries; the few available ones have used passive surveillance ( the National Neonatal Perinatal Database [NNPD] and the Asia-Pacific Neonatal Infections Study [APNIS]. Most of the other studies from low-income and middle-income countries are typically from a single site, retrospective, or have relied on routine laboratory reports.  They often lack rigorous data collection and reporting methods, and run the risk of misclassification and underestimation or overestimation of the incidence of sepsis.  The paucity of high-quality data has undermined the recognition of neonatal sepsis as an area of serious concern in public health, the implementation of measures aimed at improvement of health-systems, and investments in research and innovation in low-income and middle-income countries

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 30.00 Day(s)(—)
性别
All

入选标准

  • All neonates with culture positive sepsis in NICU, Government medical College and Hospital Aurangabad from January 2021 to March 2025.

排除标准

  • All neonates with sterile culture reports.

结局指标

主要结局

To study the incidence of MDR and XDR in NICU

时间窗: 4 weeks

次要结局

  • • Mortality(• Duration of hospital stay)

研究者

发起方
Dr Sonali Amol Avale
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sonali Amol Avale

Government Medical college , Sambhaji Nagar

研究点 (1)

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