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临床试验/NCT05022043
NCT05022043已完成不适用

At Admission Serum Presepsin as Early Predictor for Disease Severity and Positive Blood Culture for Neonates With Early-onset Sepsis

Tanta University1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
124
试验地点
1
主要终点
prediction of neonatal outcome

研究概览

简要总结

124 neonates aged ≤7 days with suspected EOS were clinically evaluated using SNAP-II and gave blood samples for BC, total leucocytic count (TLC), lymphocytic and neutrophil count, and ELISA estimation of serum levels of PSP, procalcitonin (PCT), and tumor necrosis factor-α (TNF-α). Enrolled neonates were categorized as Confirmed EOS: neonates with evident clinical sepsis manifestations and positive BC, Suspected EOS: neonates with evident clinical sepsis manifestations but had negative BC and No EOS included neonates free of evident clinical sepsis manifestations, had negative BC and showed no deterioration till 72-hr after admission.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

年龄范围
1 Day 至 7 Days(Child)
性别
All
接受健康志愿者

入选标准

  • included gestational age (GA) of 28-41 weeks and 5-min APGAR score of ≥7, and neonatal age of <7 days

排除标准

  • including small for gestational age, presence of a chromosomal abnormality, multiple congenital anomalies, genetic syndromes, history of premature rupture of membranes, chorioamnionitis, neonatal asphyxia, and missed inclusion criterion.

结局指标

主要结局

prediction of neonatal outcome

时间窗: one week

Ability of Serum Presepsin to disseminate neonates with confirmed EOS

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed B.Hamza

lecturer of pediatrics and neonatology

Tanta University

研究点 (1)

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