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临床试验/CTRI/2024/05/067255
CTRI/2024/05/067255尚未招募不适用

DEVELOPMENT OF A COMPREHENSIVE PERINATAL AND NEONATAL PREDICTIION MODEL FOR EARLY ONSET SEPSIS IN PRETERM NEONATES BORN LESS THAN OR EQUAL TO 34 WEEKS OF GESTATION – A PROSPECTIVE COHORT STUDY

Lady Hardinge Medical College NewDelhi1 个研究点 分布在 1 个国家目标入组 1,180 人开始时间: 2024年5月27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
1,180
试验地点
1
主要终点
Development of a “comprehensive perinatal and neonatal prediction model“

研究概览

简要总结

•       Most of the currently available early onset sepsis risk calculators are based on perinatal risk factors and are derived from the data collected in developed countries, which has altogether different organism profile (gram positive>> gram negative in former), clinical course, and outcome than developing countries  and risk factor based approach  leads to unnecessary exposure of antibiotics during the 1st week of life among asymptomatic neonates. Hence this  prospective cohort study is  aimed to develop comprehensive perinatal risk factor and neonatal clinical parameter based prediction model for early onset neonatal sepsis for babies born ≤ 34 weeks of gestation in developing country like India.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Day(s) 至 3.00 Day(s)(—)
性别
All

入选标准

  • All neonates born with ≤34 weeks of gestation.

排除标准

  • Major congenital anomaly (antenatally diagnosed or visible at birth).

结局指标

主要结局

Development of a “comprehensive perinatal and neonatal prediction model“

时间窗: Till discharge or death which ever is earlier

次要结局

  • 1.Performance of model for culture positive sepsis(2.Performance of model for probable sepsis)

研究者

发起方
Lady Hardinge Medical College NewDelhi
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DR SUSHMA NANGIA

Lady hardinge medical college

研究点 (1)

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